Vaccine Therapy in Treating Patients With Stage IV Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: D1/3-MAGE-3-His fusion protein
* Biological: SB-AS02B adjuvant


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: D1/3-MAGE-3-His fusion protein|nan|
|Biological: SB-AS02B adjuvant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma