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Sponsored by: |
Genzyme |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004025 |
RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells.
Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Biological: aldesleukin Biological: dendritic cell-gp100-MART-1 antigen vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma |
Estimated Enrollment: | 36 |
Study Start Date: | March 1999 |
OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma. II. Evaluate the cellular response and efficacy of these regimens in this patient population.
OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV metastatic melanoma Unresectable disease for which no other therapy exists Measurable or evaluable disease by clinical or radiographic evaluation Metastatic tumor tissue expressing both gp100 and MART-1 No uncontrolled or progressive CNS involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No clinically significant hematologic disorder Hepatic: Bilirubin less than 2.0 mg/dL No clinically significant hepatic disease Hepatitis B surface antigen negative Renal: Creatinine less than 2.0 mg/dL No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test HIV-1 and HIV-2 negative HTLV-1 negative No significant psychiatric disorder that would prevent compliance No underlying condition that would preclude study therapy No autoimmune disease or other major immune system illness No active infection requiring parenteral antibiotic therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with vaccines directed at MART-1 or gp100 melanoma antigens Prior interleukin-2 or interferon therapy allowed Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery (except study biopsies) and recovered Other: At least 4 weeks since prior experimental therapy and recovered At least 4 weeks since prior immunosuppressive drugs and recovered No other concurrent experimental therapy or anti-cancer drugs No concurrent immunosuppressive therapy
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Texas | |
U.S. Oncology | |
Houston, Texas, United States, 77060 |
Study Chair: | Amy E. Bock | Genzyme |
Study ID Numbers: | CDR0000067245, GENZ-ML98-0501, DFCI-98258 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004025 History of Changes |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Anti-HIV Agents Adenoviridae Infections Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents |
Interleukin-2 Analgesics, Non-Narcotic Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Peripheral Nervous System Agents Nevus Analgesics |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Antiviral Agents Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms |
Aldesleukin Anti-Retroviral Agents Sensory System Agents Analgesics, Non-Narcotic Interleukin-2 Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Peripheral Nervous System Agents Analgesics Central Nervous System Agents |