Seattle,
Washington
98195
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