Trials / Completed
CompletedNCT00045149
Biological Therapy in Treating Patients With Metastatic Melanoma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- 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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aldesleukin | |
| BIOLOGICAL | therapeutic tumor infiltrating lymphocytes |
Timeline
- Start date
- 2002-10-01
- Completion
- 2005-06-01
- First posted
- 2003-05-28
- Last updated
- 2010-05-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00045149. Inclusion in this directory is not an endorsement.