Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Study Details
Study Description
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
OBJECTIVES:
- Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
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Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
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Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
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Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A. 6MHP vaccine 200 mcg vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51) |
Biological: IFA
vaccine adjuvant
Other Names:
Biological: 6MHP
melanoma helper peptides
Other Names:
Biological: GM-CSF
vaccine adjuvant
Other Names:
|
| Experimental: Arm B. 6MHP vaccine 400 mcg vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51) |
Biological: IFA
vaccine adjuvant
Other Names:
Biological: 6MHP
melanoma helper peptides
Other Names:
Biological: GM-CSF
vaccine adjuvant
Other Names:
|
| Experimental: Arm C. 6MHP vaccine 800 mcg vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51) |
Biological: IFA
vaccine adjuvant
Other Names:
Biological: 6MHP
melanoma helper peptides
Other Names:
Biological: GM-CSF
vaccine adjuvant
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety: Dose-limiting toxicity [During study period]
Toxicities measured by CTCAE.
- Immunogenicity [day 22]
Melanoma peptide-specific helper T cell responses in the sentinel immunized node (SIN) on day 22.
Secondary Outcome Measures
- Immune response in the blood [day 50]
Immune response measured in the blood, by proliferation assay, over time during the study.
- DTH response [by day 85]
Delayed-type hypersensitivity response to tumor peptides
- Clinical outcome [during the study]
Clinical tumor response
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of stage IIIB, IIIC, or IV melanoma
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HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
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Brain metastases allowed at the discretion of the principle investigator
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
-
Absolute neutrophil count > 1,000/mm^3
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Platelet count > 100,000/mm ^3
-
Hemoglobin > 9 g/dL
Hepatic
- Liver function tests ≤ 2.5 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV heart disease
Other
-
Prior diagnosis of other cancer allowed
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Not pregnant or nursing
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Weight ≥ 110 pounds
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No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
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More than 4 weeks since prior growth factors
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More than 4 weeks since prior allergy shots
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More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
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No prior vaccination with any of the peptides used in this study
Chemotherapy
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- More than 4 weeks since prior steroids
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
-
More than 1 month since prior investigational drugs or therapies
-
No other concurrent investigational drugs or therapies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- University of Virginia
- National Cancer Institute (NCI)
Investigators
- Study Chair: Craig L. Slingluff, MD, University of Virginia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10464
- UVACC-MEL-41
- UVACC-28502