Status:
UNKNOWN
Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Blumenthal Cancer Center at Carolinas Medical Center
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURP...
Detailed Description
OBJECTIVES: * Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. * Assess the toxicity of th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven renal cell cancer that is metastatic
- No greater than 50% estimated hepatic replacement by tumor on CT or MRI
- No symptomatic involvement of the CNS or a major nerve
- Measurable disease required
- Ineligible for treatment with low-dose interleukin-2 on another CMC protocol
- PATIENT CHARACTERISTICS:
- Age:
- 18 and over
- Performance status:
- Karnofsky 50%-100%
- Life expectancy:
- More than 3 months
- Hematopoietic:
- No coagulopathy (i.e., platelet count less than 80,000/mm3)
- Hepatic:
- AST and ALT no greater than 5 times normal
- Renal:
- Creatinine less than 4.0 mg/dL
- Cardiovascular:
- No symptomatic angina
- No untreated coronary artery disease
- No refractory arrhythmia
- No abnormal left ventricular function
- Pulmonary:
- No dyspnea on minimal exertion
- Other:
- No site of ongoing bleeding
- No systemic infection
- No HIV antibody
- No HBsAg
- No requirement for steroids
- No psychiatric disease that precludes informed consent or protocol treatment
- No second malignancy except:
- Basal cell skin carcinoma
- Carcinoma in situ of the cervix
- Not pregnant or nursing
- Effective contraception required of fertile women
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior interleukin-2
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 28 days since prior treatment for renal cell cancer
Exclusion
Key Trial Info
Start Date :
September 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00002847
Start Date
September 1 1995
Last Update
December 19 2013
Active Locations (1)
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1
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861