Expired Study
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Los Angeles, California 90095


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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