Biological Therapy in Treating Patients With Metastatic Melanoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
|Melanoma (Skin)||Biological: aldesleukin Biological: therapeutic tumor infiltrating lymphocytes||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA|
|Study Start Date:||October 1995|
|Study Completion Date:||March 2006|
- Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.
- Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.
- Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.
OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for approximately 1 year after the last infusion.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002786
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Cassian Yee, MD||Fred Hutchinson Cancer Research Center|