Patient case: 62-year-old female with mucosal melanoma; genetic feature: KIT (L576P), KIT amplification

Clinical trial: Vaccine Therapy in Treating Patients With Metastatic Melanoma

Summary: RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
  PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
  Secondary
  -  Determine immunologic response in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
  Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed periodically until disease progression.
  PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of melanoma
  -  Metastatic disease
  -  The following melanoma subtypes are eligible:
  -  Unresectable, stage III-IV uveal melanoma
  -  Metastatic mucosal melanoma
  -  Measurable disease after attempted curative surgical therapy
  -  Tumor tissue must be available for immunohistochemical staining
  -  Positive for ≥ 1 of the following peptides:
  -  MART-1: 26-35 (27L)
  -  gp100: 209-217 (210M)
  -  Tyrosinase: 368-376 (370D)
  -  HLA-A *0201 positive by DNA polymerase chain reaction assay
  PATIENT CHARACTERISTICS:
  -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  -  Creatinine ≤ 2.0 mg/dL
  -  Bilirubin ≤ 2.0 mg/dL
  -  WBC ≥ 3,000/mm^3
  -  Platelet count ≥ 75,000/mm^3
  -  Hemoglobin ≥ 9.0 g/dL
  -  No major systemic infections
  -  No coagulation disorders
  -  No major medical illness of the cardiovascular or respiratory system
  -  No myocardial infarction within the past 6 months
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No known HIV positivity
  -  No know positivity for hepatitis B surface antigen or hepatitis C antibody
  -  No prior uveitis or autoimmune inflammatory eye disease
  -  No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No more than 1 prior cytotoxic chemotherapy agent or regimen
  -  Prior biologic or antiangiogenic therapies allowed
  -  More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
  -  No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
  -  No concurrent steroid therapy

Relevance to patient case: not relevant