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Phase II Study of Immunization Comprising Immunodominant Peptides from 3 Melanoma Antigens (MART-1, gp100, and Tyrosinase) in Patients With Refractory Metastatic Melanoma (Summary Last Modified 10/2000)
Alternate Title Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Objectives I. Identify whether patients with refractory metastatic melanoma undergo clinical response to immunization comprising immunodominant peptides from 3 melanoma antigens (MART-1, gp100, and tyrosinase) alone (arm closed) or when combined with 1 of 3 adjuvants. II. Identify the immunologic response to peptide immunization alone (arm closed) or when combined with 1 of 3 adjuvants, as measured principally by changes in T-cell precursors from before treatment until after treatment. III. Evaluate the immunologic parameter changes in a variety of possible assays in patients treated with this regimen. IV. Evaluate the toxicity profiles of peptide immunization alone (arm closed) or when combined with 1 of 3 adjuvants in these patients. Entry Criteria Disease Characteristics: Histologically confirmed refractory metastatic melanoma Measurable disease Must be HLA-A0201 Prior/Concurrent Therapy: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroids or other endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Prior surgery allowed Patient Characteristics: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular illness Pulmonary: No major pulmonary illness Other: HIV negative Hepatitis B surface antigen negative No active systemic infection No known immunodeficiency disease No known allergic reaction to Montanide ISA-51 Not pregnant Fertile patients must use effective contraception Expected Enrollment A maximum of 114 patients will be accrued for this study within 1.5 years. Outline Patients receive peptide immunization comprising MART-1:27-35, gp100:209-217, gp100:280-288, and tyrosinase:368-376. Patients receive 4 different peptides separately emulsified in Montanide ISA-51 via 4 separate subcutaneous injections into 4 different sites. Treatment repeats every 3 weeks for 4 courses. (Arm closed) Patients are treated with peptide immunization alone or combined with 1 of 3 adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV (cohort closed), or sargramostim (GM-CSF) subcutaneously) depending on the time of entry into study and response to treatment. At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual for the other cohorts. Any patient who develops unacceptable toxicity due to vaccine injections is taken off study. If a second patient develops unacceptable toxicity, then that schedule of peptide administration is discontinued. Any patient who develops unacceptable toxicity due to cytokine treatment which is not reversed within 96 hours is taken off study. Patients with stable or responding disease may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses. Trial Lead Organizations NCI - Center for Cancer Research
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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