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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC0575 | Other Identifier | Mayo Clinic Cancer Center | |
| 06-002650 | Other Identifier | Mayo Clinic IRB | |
| NCI-2009-1306 | Registry Identifier | NCI-CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
OBJECTIVES:
OUTLINE: This is a pilot study. Patients are stratified according to disease stage (II vs III or IV). Patients are sequentially enrolled into 1 of 4 different dose schedules.
Cohorts of 5 patients receive treatment at subsequent dose schedule until the maximum tolerated dose schedule (MTDS) is determined. The MTDS is defined as the dose schedule preceding that at which 2 of 5 patients experience dose-limiting toxicity within the first course.
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MART1 Analog, gp100 and Survivin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MART-1 antigen | Biological | 1000 mcg; Day 1 of a 21 day cycle x 4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels | 12 weeks | |
| Number and severity of hematologic and nonhematologic toxicities observed at each dose level | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed-type hypersensitivity positivity | 12 weeks | |
| Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels | 12 weeks | |
| Time to treatment failure |
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DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Completely resected disease
No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
HLA-A2 positive
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, MD, PhD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| IL-2 |
| Biological |
0.5x10^6/m^2 |
|
|
| gp100 antigen | Biological | 1000 mcg; Day 1 of a 21 day cycle x 4 |
|
| GM-CSF | Biological | 300mcg |
|
|
| MART-1a peptide | Biological | 1000 mcg; Day 1 of a 21 day cycle x 4 |
|
| 12 weeks |
| Time to progression | 24 months |
| 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 |
|---|---|
| D058965 | MART-1 Antigen |
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D058950 | Melanoma-Specific Antigens |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
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