Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Recurrent Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 I...
Detailed Description
OBJECTIVES: I. Determine the adverse event profile and maximum tolerated dose of interferon alfa-2b when combined with azacitidine in patients with unresectable stage III or IV melanoma or unresectab...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00217542
Start Date
July 1 2005
Last Update
May 3 2013
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520-8032