Status:
COMPLETED
Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma. * Determine if the MTD of this regimen is...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00398450
Start Date
February 1 2006
End Date
April 1 2010
Last Update
March 3 2021
Active Locations (1)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658