Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Biological Therapy in Treating Patients With Metastatic Melanoma

Summary: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
  PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Detailed description: OBJECTIVES:
  -  Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.
  -  Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.
  -  Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.
  OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed for approximately 1 year after the last infusion.
  PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histopathologically proven metastatic melanoma
  -  No CNS metastases
  -  HLA-A2 positive
  -  Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI)
  -  Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery
  PATIENT CHARACTERISTICS:
  Age
  -  18 to 75
  Performance status
  -  Karnofsky 80-100%
  Life expectancy
  -  More than 16 weeks
  Hematopoietic
  -  WBC greater than 4,000/mm^3
  -  Absolute neutrophil count greater than 2,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  -  Hematocrit greater than 30%
  Hepatic
  -  Bilirubin no greater than 1.6 mg/dL
  -  SGOT no greater than 150 IU (or no greater than 3 times normal)
  -  Prothrombin time no greater than 1.5 times control
  Renal
  -  Creatinine no greater than 2.0 mg/dL
  -  Calcium no greater than 12 mg/dL
  Cardiovascular
  -  No congestive heart failure
  -  No clinically significant hypotension
  -  No symptoms of coronary artery disease
  -  No arrhythmia on EKG requiring drug therapy
  Pulmonary
  -  No severe chronic obstructive pulmonary disease
  -  FEV_1 at least 1.0 L
  -  DLCO at least 45% of predicted
  Other
  -  No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study
  -  No systemic infection requiring chronic maintenance or suppressive therapy
  -  HIV negative
  -  No history of seizures
  -  No retinitis or choroiditis
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use adequate contraception
  -  Peripheral blood samples available weekly for 4 consecutive weeks
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  At least 4 weeks since other prior immunotherapy
  Chemotherapy
  -  1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease
  -  At least 4 weeks since prior standard or investigational chemotherapy
  Endocrine therapy
  -  At least 4 weeks since prior steroid therapy
  Radiotherapy
  -  At least 4 weeks since prior radiotherapy
  Surgery
  -  Not specified
  Other
  -  At least 4 weeks since other prior investigational drug therapy and recovered

Relevance to patient case: not relevant