Trial Outcomes & Findings for Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer (NCT NCT00670748)
NCT ID: NCT00670748
Last Updated: 2019-11-19
Results Overview
Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Approximately 3 years
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
7
|
5
|
|
Overall Study
COMPLETED
|
14
|
14
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Overall Study
Death during treatment
|
1
|
1
|
1
|
0
|
|
Overall Study
Not off study
|
2
|
1
|
1
|
1
|
Baseline Characteristics
Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer
Baseline characteristics by cohort
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 Participants
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 Participants
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
38.9 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
44.4 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
38.8 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 13.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 yearsResponse was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 Participants
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 Participants
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
6 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
7 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Not Evaluable
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month post treatmentImmunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.
Outcome measures
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 Participants
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 Participants
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells
|
16 Participants
|
16 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately, 66 months and 10 daysHere is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 Participants
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 Participants
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 Participants
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
17 Participants
|
16 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 participants at risk
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 participants at risk
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 participants at risk
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 participants at risk
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Infections and infestations
Infection
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
Other adverse events
| Measure |
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC
n=17 participants at risk
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa
n=16 participants at risk
Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.
Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
|
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC
n=7 participants at risk
Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide \& fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) \& high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.
Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.
ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa
n=5 participants at risk
Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.2%
15/17 • Number of events 15 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
87.5%
14/16 • Number of events 14 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
57.1%
4/7 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
80.0%
4/5 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
17/17 • Number of events 17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
16/16 • Number of events 16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
17/17 • Number of events 17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
16/16 • Number of events 16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
17/17 • Number of events 17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
16/16 • Number of events 16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
Platelets
|
82.4%
14/17 • Number of events 14 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
16/16 • Number of events 16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
85.7%
6/7 • Number of events 6 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Cardiac disorders
Hypotension
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Eye disorders
Hemorrhage/Bleeding - Other (Hemorrhage sub-retinal OS)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Infections and infestations
Febrile neutropenia
|
70.6%
12/17 • Number of events 12 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
81.2%
13/16 • Number of events 13 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
71.4%
5/7 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
80.0%
4/5 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Infections and infestations
Infection
|
29.4%
5/17 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
29.4%
5/17 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
37.5%
6/16 • Number of events 6 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
29.4%
5/17 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
68.8%
11/16 • Number of events 11 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
57.1%
4/7 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (fracture: right acetabulum)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Nervous system disorders
Confusion
|
23.5%
4/17 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
11.8%
2/17 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
General disorders
Pain
|
23.5%
4/17 • Number of events 4 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
41.2%
7/17 • Number of events 7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
62.5%
10/16 • Number of events 10 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.6%
3/17 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
50.0%
8/16 • Number of events 8 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (low urine output)
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Vascular disorders
Acute vascular leak syndrome
|
5.9%
1/17 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromoboplastin Time)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Blood and lymphatic system disorders
CD4 count
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately, 66 months and 10 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place