A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer
- Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in
patients with locally advanced or metastatic renal cell cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine, preliminarily, any antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2,
patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, 20 additional patients are treated at that dose level.
Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Primary Purpose: Treatment
Robert J. Motzer, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|