Status:
COMPLETED
Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Centre Leon Berard
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 gi...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa. Secondar...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell adenocarcinoma
- More than one resectable metastatic site
- No unresectable lesions after local curative treatment (i.e., radiotherapy)
- In case of secondary lesions suspected on imaging (\< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy OR disease progression documented by imaging performed over several weeks
- If patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques
- Nephrectomized
- Measurable or evaluable disease
- No brain metastases
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 90-100%
- Hematocrit ≥ 30%
- WBC ≥ 4,000/mm\^3
- Platelet count ≥ 120,000/mm\^3
- Bilirubin normal
- Creatinine ≤ 1.7 mg/dL
- FEV\_1 ≥ 50%
- No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following:
- Congestive heart failure
- Coronary artery disease
- Uncontrolled hypertension
- Severe arrhythmia
- No active infections requiring antibiotic treatment
- No severe neuropsychiatric condition
- No geographical, psychological, or familial conditions that would preclude study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF ≥ 50%
- No severe autoimmune disease
- No known chronic hepatitis
- No HIV positivity
- No hepatitis B surface antigen positivity
- No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix
- No severe pulmonary, hepatic, or renal condition that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior wide-field radiotherapy
- No prior allograft
- No prior cytokines or chemotherapy
- No concurrent corticosteroids
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00416871
End Date
February 1 2006
Last Update
September 26 2012
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