Phase III Randomized Study of Interferon alfa Versus CCI-779 Versus Interferon alfa and CCI-779 in Patients With Poor Prognosis Stage IV or Recurrent Renal Cell Carcinoma
|Phase III||Treatment||Closed||18 and over||NCI, Pharmaceutical / Industry||UCLA-0305091|
CCI-779 and interferon alfa may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether either interferon alfa alone or CCI-779 alone are more effective than interferon alfa combined with CCI-779 in treating renal cell carcinoma (kidney cancer).
This randomized phase III trial is studying interferon alfa alone or CCI-779 alone to see how well they work compared to interferon alfa and CCI-779 in treating patients with recurrent or stage IV renal cell carcinoma (kidney cancer).
Eligibility criteria include the following:
- At least 18 years old
- Measurable disease
- More than 4 weeks since radiation therapy or surgery
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned to one of three groups.
Patients in group one will receive an injection of interferon alfa three times a week.
Patients in group two will receive an infusion of CCI-779 once a week.
Patients in group three will receive an injection of interferon alfa alone three times in week 1. Beginning in week 2, they will receive an injection of interferon alfa three times a week and an infusion of CCI-779 once a week.
Treatment in all groups may be repeated for as long as benefit is shown. Patients will be evaluated every 2 months.
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
Jonsson Comprehensive Cancer Center at UCLA
|Robert Figlin, MD, FACP, Principal investigator (Contact information may not be current)|
|Official Title||A Phase III, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma|
|Trial Start Date||2003-08-06|
|Registered in ClinicalTrials.gov||NCT00065468|
|Date Submitted to PDQ||2003-08-28|
|Information Last Verified||2005-03-24|
|NCI Grant/Contract Number||CA16042|