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Sponsored by: |
Centre Leon Berard |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416429 |
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.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: aldesleukin Drug: medroxyprogesterone Drug: recombinant interferon alpha-2a |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO] |
Estimated Enrollment: | 456 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic renal cell adenocarcinoma, meeting 1 of the following criteria:
Sole metastatic site with Karnofsky score = 80%
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:
Study ID Numbers: | CDR0000468571, LEONB-PERCY-QUATTRO, EU-20605, LEONB-ET99-058, ROCHE-LEONB-PERCY-QUATTRO, CHIRON-LEONB-PERCY-QUATTRO |
Study First Received: | December 27, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00416429 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Medroxyprogesterone 17-Acetate Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Aldesleukin |
Urologic Diseases Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Medroxyprogesterone Kidney Diseases Interferon Alfa-2a Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immunologic Factors Contraceptive Agents Antineoplastic Agents Growth Substances Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Contraceptives, Oral, Synthetic Angiogenesis Modulating Agents Growth Inhibitors |