Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Detailed description
OBJECTIVES: * Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant. * Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen. * Determine the 6-month progression-free survival rate of patients treated with this regimen. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine immune responses in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Interventions
BIOLOGICALD1/3-MAGE-3-His fusion protein
BIOLOGICALSB-AS02B adjuvant
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion * M1a or M1b disease * Measurable disease outside prior field of limb perfusion * Metastatic mucosal melanoma allowed * MAGE-3 positive by reverse transcription polymerase chain reaction * No uveal or choroidal primary melanoma * No prior or concurrent brain metastases by CT scan or MRI of the brain PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Hepatitis B surface antigen negative * Hepatitis C negative * No liver cirrhosis * No unstable liver disease * No coagulation disorders Renal * Not specified Cardiovascular * No major cardiovascular illness * No myocardial infarction within the past 6 months Pulmonary * No major pulmonary illness Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No AIDS or HIV-1-associated complex * No chronic alcohol abuse or drug addiction * No systemic infections * No prior active autoimmune disease * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior adjuvant biologic therapy * No prior biologic therapy for stage IV melanoma * No prior MAGE-3 peptide or protein vaccine preparation Chemotherapy * At least 4 weeks since prior adjuvant chemotherapy * No prior chemotherapy for stage IV melanoma Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior adjuvant radiotherapy Surgery * At least 4 weeks since prior surgery Other * See Disease Characteristics * At least 3 weeks since prior limb perfusion and recovered * At least 4 weeks since other prior adjuvant therapy * No other prior therapy for stage IV melanoma
Countries
United States
Outcome results
None listed