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About
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 cells. It is not yet known whether giving medroxyprogesterone, interferon, or aldesleukin alone is more effective than giving interferon together with aldesleukin in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or aldesleukin to see how well they work when given alone compared to interferon combined with aldesleukin in treating patients with metastatic kidney cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 4 treatment arms.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 456 patients will be accrued for this study.
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Inclusion and exclusion criteria
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%
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:
Prior metastases allowed provided the following criteria are met:
No evidence of active brain metastases
Prior brain metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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