Trial Outcomes & Findings for αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies (NCT NCT02151448)
NCT ID: NCT02151448
Last Updated: 2020-07-20
Results Overview
Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2020-07-20
Participant Flow
Participant milestones
| Measure |
α DC1 Vaccine + Chemokine Modulatory Regimen
Phase 1:
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
Phase 2 α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Phase 1
STARTED
|
9
|
|
Phase 1
COMPLETED
|
9
|
|
Phase 1
NOT COMPLETED
|
0
|
|
Phase 2
STARTED
|
55
|
|
Phase 2
COMPLETED
|
55
|
|
Phase 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
Baseline characteristics by cohort
| Measure |
α DC1 Vaccine + 1 Cycle of Chemokine Modulatory Regimen
n=64 Participants
Phase 1:
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
Phase 2:
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Age, Continuous
|
53 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Only includes patients participating in the Phase 1 portion.
Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=9 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Recommended Phase 2 Dose (RP2D) (Phase 1)
5 MU/M^2IFN alpha
|
5 Participants
|
|
Recommended Phase 2 Dose (RP2D) (Phase 1)
10 MU/M^2 IFN alpha
|
0 Participants
|
|
Recommended Phase 2 Dose (RP2D) (Phase 1)
20 MU/M^2IFN alpha (RP2D)
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.
Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=38 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Sinus bradycardia : Grade 1-2
|
2 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Anemia : Grade 1-2
|
3 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Anemia : Grade 3-4
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Blurred vision : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Blurred vision : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Bruising : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Bruising : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Chills : Grade 1-2
|
34 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Chills : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Diarrhea : Grade 1-2
|
7 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Diarrhea : Grade 3-4
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Dizziness : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Dizziness : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Eye disorders - Other, specify : Grade 1-2
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Eye disorders - Other, specify : Grade 3-4
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Fatigue : Grade 1-2
|
15 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Fatigue : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Fever : Grade 1-2
|
7 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Fever : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Flu like symptoms : Grade 1-2
|
5 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Flu like symptoms : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Flushing : Grade 1-2
|
3 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Flushing : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
General disorders and administration : Grade 1-2
|
7 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
General disorders and administration: Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Headache : Grade 1-2
|
10 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Headache : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Heart failure : Grade 1-2
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Heart failure : Grade 3-4
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Hypotension : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Hypotension : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Hypothyroidism : Grade 1-2
|
2 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Hypothyroidism : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Lymphocyte count decreased : Grade 1-2
|
4 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Lymphocyte count decreased : Grade 3-4
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Myalgia : Grade 1-2
|
3 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Myalgia : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Nausea : Grade 1-2
|
13 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Nausea : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Neutrophil count decreased : Grade 1-2
|
3 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Neutrophil count decreased : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Pain : Grade 1-2
|
6 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Pain : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Platelet count decreased : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Platelet count decreased : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Pleural effusion : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Pleural effusion : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Serum amylase increased : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Serum amylase increased : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Sinus bradycardia : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Vomiting : Grade 1-2
|
7 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Vomiting : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Weight gain : Grade 1-2
|
1 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
Weight gain : Grade 3-4
|
0 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
White blood cell decreased : Grade 1-2
|
3 Participants
|
|
Adverse Events Possibly, Probably or Definitely Related to Study Treatment
White blood cell decreased : Grade 3-4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to18 monthsPopulation: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery and response to treatment.
The length of time from the start of treatment until disease progression, per RECIST 1.1 considering only patients whose deaths were from cancer. Disease progression per RECIST 1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=55 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Time to Progression (TTP)
|
15.9 months
Interval 13.6 to
Upper bound not reached for 95% CI
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery.
The length of time from the start of treatment that diagnosed patients are still alive.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=64 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Overall Survival (OS)
|
52 months
Interval 44.0 to
Upper bound of 95% CI not reached.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment.
The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=20 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Progression-free Survival (PFS)
colon cancer
|
19 months
Interval 9.0 to
Upper bound not reached for 95% CI
|
|
Progression-free Survival (PFS)
appendiceal cancer
|
16 months
Interval 14.0 to
Upper bound not reached for 95% CI
|
|
Progression-free Survival (PFS)
Mesothelioma
|
NA months
Median not reached.
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Chemokine CXCL10 (Interferon gamma-induced protein 10) concentration levels measures in peripheral blood as a biomarker of anti-tumor activity. Increased levels can be predictive of good prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
CXCL10 (Interferon Gamma-induced Protein 10) Levels
Prior to vaccine administration (Week 1)
|
1221.5 pg/mL
Standard Deviation 135.4
|
|
CXCL10 (Interferon Gamma-induced Protein 10) Levels
Prior to vaccine booster (Week 4)
|
16335.0 pg/mL
Standard Deviation 59.3
|
|
CXCL10 (Interferon Gamma-induced Protein 10) Levels
After vaccine booster (Week 8)
|
137.6 pg/mL
Standard Deviation 17098.5
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
CXCL11 (C-X-C motif chemokine 11) protein concentration levels measures in peripheral blood. Increased levels can be predictive of good prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
CXCL11 (C-X-C Motif Chemokine 11) Levels
Prior to vaccine administration (Week 1)
|
359.4 pg/mL
Standard Deviation 340.2
|
|
CXCL11 (C-X-C Motif Chemokine 11) Levels
Prior to vaccine booster (Week 4)
|
12893.2 pg/mL
Standard Deviation 190.3
|
|
CXCL11 (C-X-C Motif Chemokine 11) Levels
After vaccine booster (Week 8)
|
208.9 pg/mL
Standard Deviation 5717.1
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Interleukin 10 (IL-10) (human cytokine synthesis inhibitory factor (CSIF)) concentration levels measures in peripheral blood. Increased levels of IL-10 is associated with advanced disease and poor prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Interleukin 10 (IL-10) Levels
Prior to vaccine administration (Week 1)
|
1.2 pg/ml
Standard Deviation 2.4
|
|
Interleukin 10 (IL-10) Levels
Prior to vaccine booster (Week 4)
|
7.9 pg/ml
Standard Deviation 1.4
|
|
Interleukin 10 (IL-10) Levels
After vaccine booster (Week 8)
|
7.5 pg/ml
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Interleukin 6 (IL-6) concentration levels measures in peripheral blood. Increased levels of IL-6 is associated with associated with advanced disease and poor prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Interleukin 6 (IL-6) Cytokine Levels
Prior to vaccine administration (Week 1)
|
15.2 pg/mL
Standard Deviation 10.7
|
|
Interleukin 6 (IL-6) Cytokine Levels
Prior to vaccine booster (Week 4)
|
32.8 pg/mL
Standard Deviation 19.0
|
|
Interleukin 6 (IL-6) Cytokine Levels
After vaccine booster (Week 8)
|
11.1 pg/mL
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Interleukin-8 (IL-8) cytokine concentration levels measures in peripheral blood. Increased levels of IL-8 is associated with associated with advanced disease and poor prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Interleukin-8 (IL-8) Cytokine Levels
Prior to vaccine administration (Week 1)
|
9.5 pg/mL
Standard Deviation 15.7
|
|
Interleukin-8 (IL-8) Cytokine Levels
Prior to vaccine booster (Week 4)
|
16.9 pg/mL
Standard Deviation 5.4
|
|
Interleukin-8 (IL-8) Cytokine Levels
After vaccine booster (Week 8)
|
28.6 pg/mL
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Levels of stromal derived factor 1 alpha (SDF-1A/CXCL-12) chemokine in peripheral blood. Higher levels of SDF-1A/CXCL-12 is associated with good prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=41 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels
Prior to vaccine administration (Week 1)
|
1267.3 pg/mL
Standard Deviation 5.0
|
|
Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels
Prior to vaccine booster (Week 4)
|
2160.3 pg/mL
Standard Deviation 476.8
|
|
Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels
After vaccine booster (Week 8)
|
510.0 pg/mL
Standard Deviation 852.2
|
SECONDARY outcome
Timeframe: Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)Population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.
Tumor necrosis factor (TFNα) cytokine concentration levels measures in peripheral blood. Higher TFNα levels is associated with good prognosis.
Outcome measures
| Measure |
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen
n=40 Participants
α DC1 vaccine and
Chemokine Modulatory Regimen:
Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
|
|---|---|
|
Tumor Necrosis Factor (TFNα) Cytokine Levels
Prior to vaccine administration (Week 1)
|
10.8 pg/mL
Standard Deviation 12.2
|
|
Tumor Necrosis Factor (TFNα) Cytokine Levels
Prior to vaccine booster (Week 4)
|
31.0 pg/mL
Standard Deviation 5.0
|
|
Tumor Necrosis Factor (TFNα) Cytokine Levels
After vaccine booster (Week 8)
|
17.2 pg/mL
Standard Deviation 25.4
|
Adverse Events
Vaccine + Chemokine Modulatory Regimen
Serious events: 17 serious events
Other events: 46 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Vaccine + Chemokine Modulatory Regimen
n=64 participants at risk
Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before \& after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days \& CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed \& Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.
|
|---|---|
|
Cardiac disorders
Heart failure
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Eye disorders
Eye disorders - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Infections and infestations
Wound infection
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
White blood cell decreased
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Vascular disorders
Thromboembolic event
|
1.6%
1/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.1%
2/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
2/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Serum amylase increased
|
3.1%
2/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Alkaline phosphatase increased
|
4.7%
3/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Vascular disorders
Hypertension
|
4.7%
3/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Lipase increased
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
Other adverse events
| Measure |
Vaccine + Chemokine Modulatory Regimen
n=64 participants at risk
Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before \& after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days \& CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed \& Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \& Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Weight gain
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
4/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
Flu like symptoms
|
7.8%
5/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Blood bilirubin increased
|
7.8%
5/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Creatinine increased
|
7.8%
5/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
6/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
6/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Lipase increased
|
10.9%
7/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Vascular disorders
Hypertension
|
10.9%
7/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
12.5%
8/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
Pain
|
12.5%
8/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
8/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Platelet count decreased
|
14.1%
9/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
10/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Alkaline phosphatase increased
|
15.6%
10/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Serum amylase increased
|
15.6%
10/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Lymphocyte count decreased
|
17.2%
11/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
Fever
|
18.8%
12/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
Neutrophil count decreased
|
18.8%
12/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Investigations
White blood cell decreased
|
18.8%
12/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
12/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Diarrhea
|
21.9%
14/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Nervous system disorders
Headache
|
23.4%
15/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
16/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Gastrointestinal disorders
Nausea
|
29.7%
19/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
Fatigue
|
29.7%
19/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
Blood and lymphatic system disorders
Anemia
|
54.7%
35/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
|
General disorders
Chills
|
56.2%
36/64 • 3 years, 6 months
Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits. Two Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes): CARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)
|
Additional Information
Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place