Interferon Alfa-2b |
Intron A |
Clinical Trial: Azacitidine and Interferon Alfa-2b in Treating Patients With Stage III or Stage IV Melanoma or Stage IV Kidney Cancer That Cannot Be Removed By Surgery
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005
Purpose
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-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with azacitidine may be an effective treatment for melanoma or kidney cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of 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.
| Condition | Intervention | Phase |
|---|---|---|
| Stage III melanoma Stage IV Melanoma Stage IV Renal Cell Cancer recurrent renal cell cancer Recurrent Melanoma | Drug: azacitidine Drug: interferon alfa-2b Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: cytokine therapy Procedure: growth factor antagonist therapy Procedure: interferon therapy | Phase I |
MedlinePlus related topics: Cancer; Kidney Cancer; Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Azacitidine and Interferon Alfa-2b in Patients With Unresectable Stage III or IV Melanoma or Unresectable Stage IV Renal Cell Carcinoma
OBJECTIVES:
- 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 unresectable stage IV renal cell carcinoma.
- Determine the feasibility of this regimen for future phase II trials.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive azacitidine subcutaneously (SC) once daily on days 1-4 and 15-17 and interferon alfa-2b 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 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.
Cohorts of 3-6 patients receive escalating doses of interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 2-4 months.
PROJECTED ACCRUAL: A total of 3-42 patients will be accrued for this study within 1-21 months.
Eligibility
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- 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)
Hepatic
- 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 liver metastases)
- Albumin ≥ 3.0 g/dL
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No ventricular cardiac arrhythmia
- No myocardial infarction within the past 3 months
Pulmonary
- No dyspnea at rest
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 2 weeks since prior immunotherapy
- Prior adjuvant interferon alfa for metastatic disease or in the adjuvant setting allowed
Chemotherapy
- At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- See Disease Characteristics
- At least 2 weeks since prior hormonal therapy
- At least 1 week since prior and no concurrent steroids
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- At least 2 weeks since prior minor surgery
- At least 3 weeks since prior major surgery
Other
- Recovered from all prior therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Location and Contact Information
Mario Sznol, MD, Study Chair, Yale Comprehensive Cancer Center at Yale University School of Medicine
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: September 21, 2005
Record first received: September 20, 2005
ClinicalTrials.gov Identifier: NCT00217542
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27
Resources
- Interferon Alfa-2b (Drug Digest)
- Intron A (Drug Digest)

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