Vaccine Therapy in Treating Patients With Stage IV Melanoma

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: D1/3-MAGE-3-His fusion protein; Biological: SB-AS02B adjuvant

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00042783

CDR0000069468

SWOG-S0116

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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