Status:
COMPLETED
Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Centre Leon Berard
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer. Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white blood cells to kill tumor c...
Detailed Description
OBJECTIVES: Primary * Determine the overall survival of patients with metastatic renal cell adenocarcinoma treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin. Sec...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell adenocarcinoma, meeting 1 of the following criteria:
- More than 1 metastatic site and good performance status (Karnofsky score 80-100%)
- Sole metastatic site with Karnofsky score = 80%
- Karnofsky 90% or 100% not eligible
- No combination of several metastatic sites and liver metastases and a time interval from primary tumor to metastases of \< 1 year
- Nonmeasurable disease and/or few numbers of lesions must be confirmed histologically and as progressive disease
- The following metastases are allowed:
- Lung with or without mediastinum lymph nodes
- Bone
- Pleura (solid or liquid with positive cytology)
- Thoracic lymph nodes
- Abdominal lymph nodes
- Superficial lymph nodes
- Liver
- Subcutaneous skin/tissue
- Contralateral kidney
- Nephrectomy site
- Other organs
- Prior metastases allowed provided the following criteria are met:
- Evidence of progressive disease within the past 3 months
- Metastases evaluated by noninvasive methods
- No evidence of active brain metastases
- Prior brain metastases allowed provided all of the following criteria are met:
- Disease is stable
- Reductive therapy (surgery or radiotherapy) completed at least 3 weeks prior to study entry
- Metastases have not progressed (confirmed by CT scan or MRI)
- No concurrent corticosteroids required
- PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Creatinine \< 1.8 mg/dL
- Hematocrit ≥ 30%
- WBC ≥ 4,000/mm\^3
- Platelet count ≥ 120,000/mm\^3
- Bilirubin normal
- LVEF ≥ 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- No severe infection requiring antibiotic therapy
- No chronic hepatitis
- No severe lung, liver or kidney condition that would preclude study treatment
- No hepatitis B surface antigen positivity
- No severe neuropsychiatric condition or epilepsy
- No serious thromboembolitic disorder
- No severe cardiac dysfunction (e.g., congestive heart failure, uncontrolled hypertension, serious arrhythmia, or coronary disease)
- No other prior or concurrent primary malignancies except for basal cell skin cancer or carcinoma in situ of the cervix
- No geographical, psychological, or familial condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- More than 6 weeks since prior wide-field radiotherapy
- No prior systemic chemotherapy
- No prior organ transplantation
- No prior cytokines
- No concurrent hormonal therapy
- No concurrent anticancer chemotherapy
- No concurrent corticosteroids
- No other concurrent immunotherapy
- No other concurrent investigational agents or therapies
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2005
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00416429
End Date
February 1 2005
Last Update
September 26 2012
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