Intraocular Melanoma, Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma
Brief 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.
Interventions
BIOLOGICALPEG-interferon alfa-2b
DRUGthalidomide
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as measured scans and tumor measurements every 8 weeks | — |
| Qualitative and quantitative toxicities at 30 days following study treatment | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed