drugset / Trial / NCT00416429

Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer

NCT00416429 ↗

Phase 3 Completed 456 enrolled Centre Leon Berard
RandomizedOpen-labelTreatment

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 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.

Timeline

Start
—
Primary completion
—
Completion
2005-02

Outcome

Missed primary endpoint

paper There were no significant survival differences between the 244 interferon-alfa-treated patients and 248 noninterferon-alfa patients PMID 17932908 ↗

paper Subcutaneous interleukin-2 and/or interferon-alfa provide no survival benefit in metastatic renal cancers of intermediate prognosis PMID 17932908 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon alfa-2a Protein / enzyme biologic 9e+06 iu —
Subject aldesleukin Protein / enzyme biologic 9e+06 iu —
Subject medroxyprogesterone acetate Other / unclassified 200 mg —

Indications