Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Detroit, Michigan 48201


Purpose:

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.


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


NCT ID:

NCT00042783


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.