Trial Outcomes & Findings for Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma (NCT NCT01468818)
NCT ID: NCT01468818
Last Updated: 2016-06-27
Results Overview
Response is determined by the Response Evaluation Criteria in Solid Tumors (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 the 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
18 participants
Primary outcome timeframe
Approximately 2 Years
Results posted on
2016-06-27
Participant Flow
Participant milestones
| Measure |
Immunotherapy for Metastatic Melanoma
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
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|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Immunotherapy for Metastatic Melanoma
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
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|---|---|
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Overall Study
Death during treatment
|
2
|
Baseline Characteristics
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Immunotherapy for Metastatic Melanoma
n=18 Participants
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 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
|
0 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
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 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
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 YearsResponse is determined by the Response Evaluation Criteria in Solid Tumors (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 the 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 |
Immunotherapy for Metastatic Melanoma
n=18 Participants
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
|
|---|---|
|
Objective Response in Patients With Metastatic Melanoma
Not Evaluable
|
1 participants
|
|
Objective Response in Patients With Metastatic Melanoma
Progressive Disease
|
12 participants
|
|
Objective Response in Patients With Metastatic Melanoma
Partial Response
|
5 participants
|
SECONDARY outcome
Timeframe: Once week and one month after transferPopulation: No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.
Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.
Outcome measures
Outcome data not reported
Adverse Events
Immunotherapy for Metastatic Melanoma
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immunotherapy for Metastatic Melanoma
n=18 participants at risk
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
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|---|---|
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General disorders
Death not associated with CTCAE term
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Immunotherapy for Metastatic Melanoma
n=18 participants at risk
Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
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|---|---|
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Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
6/18 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
18/18 • Number of events 18
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
18/18 • Number of events 18
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
18/18 • Number of events 18
|
|
Blood and lymphatic system disorders
Platelets
|
83.3%
15/18 • Number of events 15
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Rigors/chills
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Weight gain
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Febrile neutropenia
|
61.1%
11/18 • Number of events 11
|
|
Infections and infestations
Infection
|
33.3%
6/18 • Number of events 6
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain
|
27.8%
5/18 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Oliguria)
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.6%
1/18 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place