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| ID | Type | Description | Link |
|---|---|---|---|
| LAC-USC-10M-03-1 | |||
| NCI-6262 | |||
| LAC-USC-033307 | |||
| CDR0000480137 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2009-00050 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MART-1 antigen | Biological | |||
| gp100:209-217(210M) peptide vaccine | Biological | |||
| therapeutic autologous dendritic cells | Biological | |||
| tyrosinase peptide | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Progression-free survival | ||
| Time to progression | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Diagnosis of melanoma
Metastatic disease
The following melanoma subtypes are eligible:
Measurable disease after attempted curative surgical therapy
Tumor tissue must be available for immunohistochemical staining
Positive for ≥ 1 of the following peptides:
HLA-A *0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S. Weber, MD, PhD | University of Southern California | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States | ||
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| 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 |
|---|---|
| D058965 | MART-1 Antigen |
| D000096202 | Protein Subunit Vaccines |
| ID | Term |
|---|---|
| D058950 | Melanoma-Specific Antigens |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| University of Michigan Comprehensive Cancer Center |
| Ann Arbor |
| Michigan |
| 48109-0942 |
| United States |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |