Status:
COMPLETED
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 g...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00238329
Start Date
January 1 2001
End Date
June 1 2007
Last Update
April 8 2013
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379