Biological Therapy in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00045357|
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : September 21, 2010
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and 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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: therapeutic autologous lymphocytes||Phase 1|
- Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients.
- Determine the antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100.
Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes.
Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Official Title:||Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||August 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045357
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Cassian Yee, MD||Fred Hutchinson Cancer Research Center|