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
Recurrent Melanoma, Recurrent Renal Cell Cancer, Stage III Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: 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 No myocardial infarction within the past 3 months No dyspnea at rest Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active gastrointestinal bleeding or ulcer disease No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study agents At least 2 weeks since prior immunotherapy Prior adjuvant interferon alfa for metastatic disease or in the adjuvant setting allowed At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) See Disease Characteristics At least 2 weeks since prior hormonal therapy At least 1 week since prior and no concurrent steroids At least 3 weeks since prior radiotherapy At least 2 weeks since prior minor surgery At least 3 weeks since prior major surgery Recovered from all prior therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy, biological therapy)
Patients receive azacitidine SC once daily on days 1-4 and 15-17 and recombinant interferon alfa-2b SC on days 8, 10, 12, 15, 17, 19, 22, 24, and 26 during course 1. Beginning in course 2 and for all subsequent courses, patients receive azacitidine SC once daily on days 1-3 and 15-17 and interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 12 total courses in the absence of disease progression or unacceptable toxicity.