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 Targeting Cancer Testis Antigens 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. Treating a person's white
blood cells in the laboratory and then reinfusing them may cause a stronger immune response
and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients
who have metastatic melanoma.
OBJECTIVES:
Primary
- Determine the safety and toxicity of cellular adoptive immunotherapy comprising
autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in
patients with metastatic melanoma.
- Determine the duration of in vivo persistence of this therapy in these patients.
Secondary
- Evaluate the antitumor effects of this therapy in these patients.
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and
then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive
cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer
testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2
subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks
for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who
demonstrate a clinical response after completion of the fourth course are eligible to
receive additional T-cell infusions.
Patients are followed for 9 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
;
Masking: Open Label, Primary Purpose: Treatment
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