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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Thalidomide

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