Azacitidine and Recombinant Interferon Alfa-2b in Treating Patients With Stage III or Stage IV Melanoma or Stage IV Kidney Cancer That Cannot Be Removed By Surgery

Completed · Phase 1

Conditions studied: Recurrent Melanoma, Recurrent Renal Cell Cancer, Stage III Melanoma, Stage IV Melanoma, Stage IV Renal Cell Cancer

In brief

This phase I trial is studying the side effects and best dose of recombinant interferon alfa-2b when given together with azacitidine in treating patients with stage III or stage IV melanoma or stage IV kidney cancer that cannot be removed by surgery. 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. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving azacitidine together with recombinant interferon alfa-2b may kill more tumor cells.

Key facts

Study ID

NCT00217542

Run by

National Cancer Institute (NCI)

People needed

42

Starts

2005-07-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of 1 of the following:
• Melanoma
• Unresectable stage III disease
• Stage IV disease
• Renal cell carcinoma
• Unresectable and/or stage IV disease
• Measurable disease
• No untreated brain metastases or leptomeningeal disease
• Patients with previously treated brain metastases are eligible provided they have no evidence of progression for ≥ 4 weeks following treatment and do not require steroids
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9.0 g/dL (may be transfused to this level)
• PT or PTT < 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 2.0 mg/mL
• AST and ALT ≤ 3 times ULN (5 times ULN for patients with liver metastases)
• Albumin ≥ 3.0 g/dL
• Creatinine ≤ 1.7 mg/dL
• Creatinine clearance ≥ 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No ventricular cardiac arrhythmia

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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