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Phase II Study of Immunization with Immunodominant Tyrosinase and gp100 Peptides in Patients With Recurrent or Refractory Metastatic Melanoma
Alternate Title Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma
Special Category: NIH Clinical Center trial Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment A maximum of 457 patients will be accrued for this study over 3.5 years. Outline Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31). Patients are assigned to 1 of 4 vaccine groups:
Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) 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 on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued. Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses. Patients are followed for 4-6 weeks. 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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