Status:
COMPLETED
Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. PURPOSE: This phase II trial is studying how well interferon alfa works in treating patie...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with metastatic renal clear cell carcinoma treated with interferon alfa-1b. Secondary * Determine the toxicity of this drug ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed predominantly renal clear cell carcinoma
- Clinical evidence of OR biopsy-proven metastatic disease to a site or sites distant from the primary tumor
- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
- Good- or intermediate-risk category as defined by having ≤ 2 of the following factors:
- Time from initial diagnosis to treatment \< 1 year
- Karnofsky performance status \< 80%
- Hemoglobin \< lower limit of normal
- Corrected calcium \> 10.0 mg/dL
- Lactate dehydrogenase (LDH) \> 1.5 times upper limit of normal (ULN)
- No major clinical ascites or pleural effusion
- No CNS metastases by neurologic exam and CT scan or MRI
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.5 g/dL
- Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
- Calcium normal
- Total bilirubin ≤ 1.5 mg/dL
- AST ≤ 3.0 times normal
- Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and for the duration of study treatment
- No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- No known positivity for HIV or hepatitis B surface antigen
- No history of seizure disorders
- No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
- No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for \> 3 years
- PRIOR CONCURRENT THERAPY:
- No prior organ allografts
- No prior interferon
- No prior cytokine-based therapy for metastatic disease
- Prior radiotherapy is allowed for the control of pain from skeletal lesions provided treatment was completed \> 28 days prior to study entry and patient has recovered
- No major surgery requiring general anesthesia within 28 days prior to study entry
- No more than 2 prior therapies for metastatic disease
- No concurrent palliative radiotherapy
- No concurrent chemotherapy
- No concurrent hormonal therapy except for hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
- No concurrent steroid use except ongoing replacement therapy with physiologic doses of corticosteroids
- No concurrent dexamethasone or other steroidal anti-emetics or anti-inflammatories
- No other concurrent anticancer therapy
- No concurrent aspirin or barbiturates
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00278174
Start Date
February 1 2005
End Date
April 1 2007
Last Update
May 4 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195