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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: PEG-interferon alfa-2b
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PEG-interferon alfa-2b|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as measured scans and tumor measurements every 8 weeks |  |  | 
| Qualitative and quantitative toxicities at 30 days following study treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival by standard life table and Kaplan-Meier |  |  | 
| Overall survival by standard life table and Kaplan-Meier |  |  | 
| Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma