Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination chemotherapy works in treating patients with metastatic melanoma. Biological therapies, such as TIL, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TIL after combination chemotherapy may kill more tumor cells.
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Drug: fludarabine phosphate
Biological: therapeutic tumor infiltrating lymphocytes
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma|
- Clinical response, assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 definitions for complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- In vivo persistence of adoptively transferred T cells following TIL infusion [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
- Incidence of adverse events, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Percent expression of biomarkers [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]Logistic regression will be used to assess these correlations.
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (TIL, combination chemotherapy, aldesleukin)
Patients receive cyclophosphamide IV on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion on day 0 and receive aldesleukin IV every 8 hours on days 1-5 for up to a maximum of 14 doses.
Other Names:Drug: fludarabine phosphate
Other Names:Biological: therapeutic tumor infiltrating lymphocytes
Undergo TIL infusion
Other Name: tumor infiltrating lymphocytesBiological: aldesleukin
Other Names:Other: laboratory biomarker analysis
I. Examine the anti-tumor efficacy of cellular adoptive immunotherapy in metastatic melanoma patients using autologous tumor-infiltrating lymphocytes with a lymphodepleting conditioning regimen of cyclophosphamide and fludarabine (fludarabine phosphate), and followed by adjuvant high-dose interleukin (IL)-2 (aldesleukin).
I. Determine the in vivo persistence of transferred tumor-infiltrating lymphocytes.
II. Examine the safety of cellular adoptive immunotherapy in melanoma patients using autologous tumor-infiltrating lymphocytes, preceded by a lymphodepleting conditioning regimen of cyclophosphamide and fludarabine, and followed by adjuvant high-dose IL-2.
III. Evaluate for molecular tumor markers and immunohistochemical features that correlate with in vivo persistence and anti-tumor efficacy.
Patients receive cyclophosphamide intravenously (IV) on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion on day 0 and receive aldesleukin IV every 8 hours on days 1-5 for up to a maximum of 14 doses.
After completion of study treatment, patients are followed up at 6, 12, and 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807182
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Sylvia M. Lee 206-667-2218|
|Principal Investigator: Sylvia M. Lee|
|Principal Investigator:||Sylvia Lee||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|