Melanoma (Skin) Clinical Trial
Official title:
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways
to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the
immune system kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular
adoptive immunotherapy in treating patients who have metastatic melanoma.
OBJECTIVES:
Primary
- Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+
antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with
stage IV melanoma.
- Determine the duration of in vivo persistence of these CTL clones in these patients.
Secondary
- Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood
mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL)
clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over
30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable
toxicity. Patients also receive fludarabine IV once daily on days 14-18.
Patients are followed for up to 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.
;
Masking: Open Label, Primary Purpose: Treatment
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