Patient case: 73-year-old male with melanoma; genetic feature: tumor cells negative for PD-L1 expression

Clinical trial: Vaccine Therapy in Treating Patients With Stage IV Melanoma

Summary: 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: 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.

Eligibility: 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

Relevance to patient case: not relevant