Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

Summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.
  PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.

Detailed description: OBJECTIVES:
  -  Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
  -  Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.
  OUTLINE: This is a dose-escalation study.
  Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
  Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignancy, including, but not limited to, renal cell carcinoma, melanoma, Kaposi's sarcoma, breast carcinoma, lymphoma, myeloma, or tumors of endothelial origin
  -  Stage IV disease
  -  Refractory to standard therapy
  -  Measurable or evaluable disease
  -  Evaluable disease can include clinically or radiographically nonmeasurable tumor or specific tumor markers
  -  Patients with prior solitary CNS metastasis allowed
  -  Must have had prior definitive therapy ≥ 3 months previously
  -  No requirement for glucocorticoids unless for physiologic replacement
  -  No multiple CNS metastases
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Granulocyte count ≥ 1,500/mm³
  -  Platelet count ≥ 100,000/mm³
  -  Creatinine ≤ 1.3 times upper limit of normal (ULN) OR
  -  Creatinine clearance of 60 mL/min
  -  Bilirubin ≤ 1.3 times ULN
  -  AST ≤ 5 times ULN
  -  No pregnant or lactating women
  -  Fertile women and men, unless surgically sterile, must use effective contraception
  -  No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
  -  No congestive heart failure
  -  No angina pectoris
  -  No New York Heart Association class III or IV disease
  -  No other severe cardiovascular disease
  -  No known seizure disorder
  -  No known HIV or hepatitis B surface antigen positivity
  -  No active clinical infection requiring antibiotics within the past 7 days
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 4 months since prior interferon therapy and/or ≤ 400 million units of interferon
  -  At least 3 weeks since prior major surgery requiring general anesthesia
  -  At least 3 weeks since prior radiotherapy or chemotherapy
  -  Treatment with hormones or other chemotherapeutic agents may not be administered except for steroids given for preexisting adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
  -  No prior organ allograft
  -  No concurrent dexamethasone, other steroidal antiemetics, or anti-inflammatories
  -  No concurrent palliative radiotherapy

Relevance to patient case: not relevant