Trial Outcomes & Findings for A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas (NCT NCT02375984)
NCT ID: NCT02375984
Last Updated: 2021-09-22
Results Overview
At the end of 12 week follow up, the proportion of patients that showed clinical response (CR) determined by the disappearance of all target lesions, or partial response (PR) will be calculated. The patient is determined to have partial response as if 30% reduction in the sum of the longest diameter (SLD) of target lesions are shown from the baseline sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
12 weeks, or until development of new metastases or recurrence
Results posted on
2021-09-22
Participant Flow
Participant milestones
| Measure |
Tumor Infiltrating Lymphocytes (TIL)
Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).
Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10\^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas
Baseline characteristics by cohort
| Measure |
Tumor Infiltrating Lymphocytes (TIL)
n=1 Participants
Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).
Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10\^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.986 years
n=5 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks, or until development of new metastases or recurrencePopulation: Single patient treated, no formal statistical analysis performed
At the end of 12 week follow up, the proportion of patients that showed clinical response (CR) determined by the disappearance of all target lesions, or partial response (PR) will be calculated. The patient is determined to have partial response as if 30% reduction in the sum of the longest diameter (SLD) of target lesions are shown from the baseline sum LD.
Outcome measures
| Measure |
Tumor Infiltrating Lymphocytes (TIL)
n=1 Participants
Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).
Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10\^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down.
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|---|---|
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Clinical Response
Complete Responder
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0 Participants
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Clinical Response
Partial Responder
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0 Participants
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Clinical Response
Non Responder
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1 Participants
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SECONDARY outcome
Timeframe: 12 weeks, or until development of new metastases or recurrencePopulation: Although the single participant completed a total of 3 surveys, these were never scored or analyzed and data are not available to be reported.
Quality of Life will be assessed and scored per European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) EORTC-QLQ-C30 version 3.0 requirements. The EORTC QLQ-C30 contains subscales for global health status, and physical, emotional, role, cognitive and social function with higher scores indicating better functioning (19). The change in QOL measured throughout the study period will be examined through mixed effect model adjusting for the baseline. Akaike information criteria (AIC) will be used to determine appropriate covariance structure.
Outcome measures
Outcome data not reported
Adverse Events
Tumor Infiltrating Lymphocytes (TIL)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tumor Infiltrating Lymphocytes (TIL)
n=1 participants at risk
Patients will have a melanoma metastasis resected and cultured in IL-2 in vitro either as part of this treatment protocol or the JWCI procurement protocol. TIL from these cultures will be assessed for tumor-reactivity and those with such activity will be further expanded and adoptively transferred. Patients will receive a non-myeloablative lymphocyte-depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day X 2 days IV) and fludarabine (25 mg/m2/day IV X 5 days). Following this regimen, patients will receive an intravenous adoptive transfer of at least 109 tumor-reactive lymphocytes (TIL) followed by high-dose intravenous IL-2 (600-720,000 IU/kg/dose every 8 hours for up to 12 doses).
Tumor Infiltrating Lymphocytes (TIL): Patients will receive an IV adoptive transfer of at least 10\^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down.
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|---|---|
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Nervous system disorders
headache
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100.0%
1/1 • Number of events 2 • Single patient treated, data collected from baseline up to 72 days.
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Gastrointestinal disorders
constipation
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100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
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Eye disorders
blurred vision
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100.0%
1/1 • Number of events 2 • Single patient treated, data collected from baseline up to 72 days.
|
|
Gastrointestinal disorders
diarrhea
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
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Skin and subcutaneous tissue disorders
alopecia
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
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Metabolism and nutrition disorders
anorexia
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100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
General disorders
fatigue
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100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Gastrointestinal disorders
nausea
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
General disorders
facial pain
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Gastrointestinal disorders
abdominal pain
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
neutrophil count decreased
|
100.0%
1/1 • Number of events 2 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 2 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Psychiatric disorders
agitation
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100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Skin and subcutaneous tissue disorders
Other, sunburn
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100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
1/1 • Number of events 1 • Single patient treated, data collected from baseline up to 72 days.
|
Additional Information
Lisa van Kreuningen
Saint John's Cancer Institute (formerly John Wayne Cancer Institute)
Phone: 3105827053
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place