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Home > "M" Clinical Trials Conditions > Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma  Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer Center
Synopsis: 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. PURPOSE: Randomized phase I trial to compare the effectiveness of melanoma vaccine with or without sargramostim in treating patients who have stage IV malignant melanoma.
Details: OBJECTIVES: I. Compare the immune responses of patients with HLA-A2 positive stage IV malignant melanoma treated with tyrosinase, MART-1, and gp100 antigens emulsified in Montanide ISA-51 with or without sargramostim (GM-CSF). II. Compare the safety and toxicity of these regimens in these patients. III. Collect preliminary data on therapeutic efficacy relating to parameters of immune function in these patients on these treatments. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive melanoma specific antigen peptides comprised of tyrosinase, gp100, and MART 1:27-35 emulsified in Montanide ISA-51 subcutaneously. Vaccinations are administered at the site of the primary melanoma, and in the abdomen and the extremities (6 total injections per session) every 3 weeks for 6 months. Patients may then continue receiving vaccinations every 3 months for 1 year. Arms II and III: Patients receive vaccinations as in arm I, combined with two different concentrations of sargramostim (GM-CSF). Patients are followed every 3 months until year 3. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IV malignant melanoma that is refractory to standard treatment or for which no curative therapy exists - Measurable disease - HLA-A2 positive - No known CNS metastases or carcinomatous meningitis --Prior/Concurrent Therapy-- Biologic therapy: - No prior tyrosinase peptide, gp100 antigen, or MART-1:27-35 antigen - At least 4 weeks since prior biologic therapy or immunotherapy No other concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (at least 6 weeks since prior mitomycin or nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy involving no more than 25% of bone marrow - No concurrent radiotherapy Surgery: Not specified --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 9.0 g/dL Hepatic: - Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association classification III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent seizure disorder - No active concurrent psychiatric disorder requiring antipsychotic medication - No concurrent uncontrolled infection - No immune deficiency - No other malignancy within the past 5 years except locally resected basal cell or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SvetomirMarkovic, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Additional Information:
Study ID Numbers: CDR0000068171; MAYO-9973,NCI-T99-0083
Study Start Date: October 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006243
Other Stage 4 Melanoma Studies:
1. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
2. Vaccine Therapy in Treating Patients With Metastatic Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV Melanoma
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
5. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
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