Kidney Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Biological therapies such as interferon alfa use different ways
to stimulate the immune system and stop cancer cells from growing. Combining biological
therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological
therapy in treating patients who have locally advanced or metastatic kidney cancer.
OBJECTIVES:
- 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
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