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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045149 |
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.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: aldesleukin Drug: therapeutic tumor infiltrating lymphocytes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Study Start Date: | October 2002 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000256451, FHCRC-1588.00, NCI-H02-0091 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045149 |
Health Authority: | United States: Federal Government |
recurrent melanoma stage IV melanoma |
Neuroectodermal Tumors Aldesleukin Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Testicular Diseases |
Neuroepithelioma Nevus Recurrence Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Nevi and Melanomas Antiviral Agents Pharmacologic Actions |