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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003665 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: dendritic cell-MART-1 peptide vaccine Biological: gp100 antigen Biological: therapeutic tumor infiltrating lymphocytes Biological: tyrosinase peptide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase I Trial of a Dendritic Cell Vaccine for Melanoma |
Estimated Enrollment: | 40 |
Study Start Date: | April 1999 |
OBJECTIVES: I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine. II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population.
OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms. All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses. Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes. Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Patients are followed at 2 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 14 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 INR no greater than 1.5 mg/dL No coagulopathies including thrombocytopenia Hepatic: Partial thromboplastin time no greater than 50 seconds Renal: Not specified Cardiovascular: No major cardiac illness Pulmonary: No major respiratory illness Other: No active systemic infection or other illness No peripheral vascular disease Not pregnant or nursing Effective contraception required of all fertile patients during and for one month after completion of treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy No concurrent radiotherapy Surgery: Not specified
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Brian J. Czerniecki, MD, PhD | University of Pennsylvania |
Study ID Numbers: | CDR0000066759, UPCC-4697, NCI-T98-0033 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003665 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |