Biological Therapy in Treating Patients With Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00002786
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center🇺🇸Seattle, Washington, United States