Status:
COMPLETED
Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage III Cutaneous Melanoma AJCC v7
Stage IIIA Cutaneous Melanoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination chemotherapy works in treating patients with melanoma that has spread to other places in the body. Biologica...
Detailed Description
OUTLINE: Patients receive cyclophosphamide intravenously (IV) on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion over 30-60 minutes on day 0 and receive ald...
Eligibility Criteria
Inclusion
- Step I
- Stage IV melanoma or stage III melanoma that is unlikely to be cured by surgery
- Able to tolerate high-dose cyclophosphamide, fludarabine and high-dose IL-2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must have a magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET) of the brain within 2 months before consenting if known history of brain metastasis or if clinically indicated; if new lesions are present, principal investigator (PI) or designee should make final determination regarding enrollment
- Patients must have a site of metastatic disease that can be safely resected or biopsied for tissue sufficient for TIL harvest
- Step II
- Patients must have measurable metastatic melanoma
- Able to tolerate high-dose cyclophosphamide, fludarabine, and high-dose IL-2
- ECOG performance status of 0-1
- Patients must have brain imaging by MRI, CT or PET within 30 days prior to lymphodepletion; patients may have asymptomatic brain lesions that are =\< 1 cm each, lesions that are \> 1 cm that have been irradiated and in the opinion of the investigator no longer represents active disease will also be allowed
- A functional cardiac test (e.g., stress treadmill, stress thallium, multigated acquisition scan (MUGA), dobutamine echocardiogram) to rule out cardiac ischemia within 4 months prior to lymphodepletion is required for all patients
- Pulmonary function tests (PFTs) are required of all patients within 4 months prior to lymphodepletion; forced expiratory volume (FEV)1 and forced vital capacity (FVC) must be \>= 65% predicted and diffusion lung capacity for carbon monoxide (DLCO) must be \>= 50% predicted
- Patients must have their tumor sent for v-Raf murine sarcoma viral oncogene homolog B1(BRAF) mutational analysis
- Patients must have adequate TIL (at least 40 x 10\^6 cells at the pre-expansion stage)
Exclusion
- Step I
Key Trial Info
Start Date :
August 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01807182
Start Date
August 20 2013
End Date
August 26 2021
Last Update
November 10 2022
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109