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Keep this study
Lead
Barbara Ann Karmanos Cancer Institute
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma