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| ID | Type | Description | Link |
|---|---|---|---|
| UVACC-MEL-43 | |||
| FCCC-03045 | |||
| MDA-2003-0720 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52.
PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incomplete Freund's adjuvant | Biological | |||
| multi-epitope melanoma peptide vaccine | Biological | |||
| sargramostim | Biological |
DISEASE CHARACTERISTICS:
Diagnosis of melanoma
Must express HLA-A1, -A2, or -A3
No ocular melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Craig L. Slingluff, MD | University of Virginia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Cancer Institute at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24377099 | Derived | Clancy-Thompson E, King LK, Nunnley LD, Mullins IM, Slingluff CL Jr, Mullins DW. Peptide vaccination in Montanide adjuvant induces and GM-CSF increases CXCR3 and cutaneous lymphocyte antigen expression by tumor antigen-specific CD8 T cells. Cancer Immunol Res. 2013 Nov;1(5):332-9. doi: 10.1158/2326-6066.CIR-13-0084. |
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| Fox Chase Cancer Center |
| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| MD Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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| ID | Term |
|---|---|
| C114843 | incomplete Freund's adjuvant |
| C081222 | sargramostim |
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