Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.

PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma

• At least one lesion appropriate for 3 separate punch or core needle biopsies

• Must have received and failed ≥ 1 prior systemic treatment for metastatic disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT < 2 times ULN

• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol

• No uncontrolled infection

• No known HIV positivity

• No hepatitis B or hepatitis C infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior systemic therapy

• More than 4 weeks since prior radiotherapy to target lesions with evidence of progression

• No concurrent radiotherapy to target lesions

• No concurrent oral or IV corticosteroids

• Topical creams or ocular steroid drops are allowed