peg-interferon alfa-2b and thalidomide in treating patients with recurrent or metastatic melanoma

Conditions: Intraocular Melanoma; Melanoma (Skin)

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.

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 criteria:
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

Keywords: recurrent melanoma stage iv melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma iris melanoma recurrent intraocular melanoma