Patient case: 64-year-old female with melanoma; genetic feature: BRAF (E586K)

Clinical trial: Vaccine Therapy in Treating Patients With Melanoma of the Eye

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
  PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.

Detailed description: OBJECTIVES:
  -  Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
  -  Determine whether this regimen increases survival of these patients.
  -  Determine the toxicity of this regimen in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
  -  Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
  All patients are followed every 3 months for 1 year and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of ocular melanoma
  -  No melanoma of the iris
  -  Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy
  -  No more than 5 weeks since the beginning of primary tumor treatment
  -  Measurable disease
  -  At least 12.0 mm in largest diameter OR
  -  At least 6.0 mm in height
  -  HLA-A2 positive
  -  No distant metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  ECOG 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Hemoglobin at least 9 g/dL
  -  Neutrophil count at least 2,000/mm^3
  -  Lymphocyte count at least 700/mm^3
  -  Platelet count at least 100,000/mm^3
  -  No bleeding disorder
  Hepatic:
  -  Bilirubin no greater than 2.0 mg/dL
  -  AST and ALT no greater than 2 times upper limit of normal (ULN)
  -  Lactate dehydrogenase no greater than 2 times ULN
  -  Alkaline phosphatase no greater than 2 times ULN
  -  Gamma glutamyl transpeptidases no greater than 2 times ULN
  -  Hepatitis C antibody negative
  -  Hepatitis B antigen negative
  Renal:
  -  Creatinine no greater than 2.0 mg/dL
  Immunologic:
  -  No clinical immunodeficiency
  -  No autoimmune diseases
  -  No inflammatory bowel disease
  -  No active infection requiring antibiotics
  -  No multiple sclerosis
  Other:
  -  HIV negative
  -  No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
  -  No other uncontrolled illness
  -  No psychological, familial, sociological, or geographical conditions that would preclude study participation
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for at least 3 months after study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No other concurrent immunotherapy or biologic therapy
  Chemotherapy:
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  At least 3 weeks since prior steroids
  -  No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day)
  -  Concurrent topical or inhalation steroids allowed
  -  No concurrent hormonal therapy
  Radiotherapy:
  -  See Disease Characteristics
  -  Prior proton beam therapy allowed
  -  Prior brachytherapy without tumor resection allowed
  -  Recovered from prior radiotherapy
  -  No prior radiotherapy to the spleen
  -  No prior pre-enucleation radiotherapy
  -  No prior ruthenium Ru 106 as primary therapy alone
  -  No concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  -  Prior transcleral tumor resection allowed
  -  Recovered from prior surgery
  -  No prior major organ allograft
  -  No prior splenectomy
  Other:
  -  No other concurrent investigational drugs
  -  No concurrent systemic immunosuppressive drugs

Relevance to patient case: not relevant