Biological Therapy in Treating Patients With Metastatic Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00045149
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2002-09-06
• Study Start: 2002-10
• Study First Submitted QC: 2003-05-27
• Study First Posted: 2003-05-28
• Study Completion: 2005-06
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-05
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States