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

Clinical trial: PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

Summary: RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.
  PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.

Detailed description: OBJECTIVES:
  -  Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide.
  -  Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  -  Determine progression-free and overall survival of patients treated with this regimen.
  OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.
  PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignant melanoma, including any of the following:
  -  Cutaneous melanoma
  -  Ocular melanoma
  -  Mucosal melanoma
  -  Unidentified primary tumor
  -  Recurrent or metastatic disease
  -  Bidimensionally measurable or evaluable disease
  -  Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  SWOG 0-2
  Life expectancy
  -  At least 12 weeks
  Hematopoietic
  -  Absolute granulocyte count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  Hepatic
  -  Bilirubin ≤ 2 times upper limit of normal (ULN)
  -  SGOT ≤ 2 times ULN
  Renal
  -  Creatinine ≤ 2 mg/dL
  Cardiovascular
  -  None of the following conditions within the past 3 months:
  -  Congestive heart failure
  -  Second- or third-degree heart block
  -  Myocardial infarction
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  -  No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
  -  No concurrent blood, sperm, or ova donation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Prior biologic therapy (e.g., interferon) allowed
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  See Disease Characteristics
  -  At least 28 days since prior radiotherapy
  Surgery
  -  At least 28 days since prior surgery
  Other
  -  No more than 2 prior systemic treatment regimens for metastatic malignant melanoma

Relevance to patient case: not relevant