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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019487 |
RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: aldesleukin Biological: gp209-2M antigen Biological: incomplete Freund's adjuvant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide |
Study Start Date: | November 1998 |
OBJECTIVES:
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells.
Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
For patients randomized to receive interleukin-2:
Pulmonary:
For patients randomized to receive interleukin-2:
Other:
For patients randomized to receive interleukin-2:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000066287, NCI-98-C-0095, NCI-T98-0012 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00019487 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Anti-HIV Agents Immunologic Factors Adjuvants, Immunologic Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Aldesleukin Anti-Retroviral Agents Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Freund's Adjuvant Nevus |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Anti-Retroviral Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |