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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-98-C-0022 | |||
| NCI-T97-0088 |
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.
OBJECTIVES:
OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).
Patients are assigned to 1 of 4 vaccine groups:
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.
PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| incomplete Freund's adjuvant | Biological | |||
| sargramostim | Biological | |||
| tyrosinase peptide | Biological | |||
| tyrosinase-related protein-1 | Biological |
DISEASE CHARACTERISTICS:
Histologically proven refractory metastatic melanoma
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery Branch | Bethesda | Maryland | 20892 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| C114843 | incomplete Freund's adjuvant |
| C081222 | sargramostim |
| C064056 | tyrosinase-related protein-1 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |