Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Summary: RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells.
  PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox.
  Secondary
  -  Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug.
  -  Determine the toxicity profile of this drug in these patients.
  OUTLINE: Patients are stratified according to disease type (metastatic melanoma vs metastatic kidney cancer).
  Patients receive denileukin diftitox IV over 1 hour on days 1-5, 21-25, 42-46, and 63-67. Treatment repeats every 84 days (12 weeks) for up to a maximum total of 5 courses in the absence of disease progression, autoimmune ocular toxicity attributable to denileukin diftitox, or any other unacceptable toxicity. At any time during therapy, patients achieving a complete response receive 1 additional course of therapy after the complete response.
  PROJECTED ACCRUAL: A total of 10-96 patients (5-48 per stratum) will be accrued for this study within 3-4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Melanoma
  -  Kidney cancer
  -  Metastatic disease
  -  Measurable disease
  -  Documented disease progression while receiving standard therapy
  -  No resectable local or regional disease
  PATIENT CHARACTERISTICS:
  Age
  -  16 and over
  Performance status
  -  ECOG 0-2
  Life expectancy
  -  More than 3 months
  Hematopoietic
  -  WBC ≥ 3,000/mm^3
  -  Platelet count ≥ 90,000/mm^3
  -  Lymphocyte count ≥ 500/mm^3
  -  No concurrent coagulation disorders
  Hepatic
  -  Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
  -  AST and ALT < 3 times normal
  -  Albumin ≥ 2.5 g/dL
  -  Hepatitis B surface antigen negative
  -  Hepatitis C antibody negative
  Renal
  -  Creatinine ≤ 2.0 mg/dL
  Cardiovascular
  -  Normal thallium stress test*
  -  No prior myocardial infarction
  -  No history of severe coronary artery disease
  -  No major medical illness of the cardiovascular system NOTE: *For patients > 50 years of age OR who have a history of cardiovascular disease
  Pulmonary
  -  No major medical illness of the respiratory system
  Immunologic
  -  HIV negative
  -  No active systemic infection
  -  No presence of opportunistic infections
  -  No primary or secondary immunodeficiency
  -  No autoimmune disease
  -  No other known immunodeficiency
  Other
  -  No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients)
  -  Willing to undergo leukapheresis
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy
  Chemotherapy
  -  Recovered from prior chemotherapy
  Endocrine therapy
  -  No concurrent systemic steroids
  Radiotherapy
  -  Recovered from prior radiotherapy
  Surgery
  -  Not specified
  Other
  -  More than 3 weeks since prior systemic anticancer therapy
  -  No other concurrent systemic anticancer therapy

Relevance to patient case: possibly relevant