NCT00317759

Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic autologous lymphocytes
DRUG	fludarabine phosphate

Timeline

• Start date: 2003-05-01
• Completion: 2008-10-01
• First posted: 2006-04-25
• Last updated: 2015-10-01

Locations

1 site across 1 country: United States