Official Title: A Phase I Study of the Safety Tolerability and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors
Status: COMPLETED
Status Verified Date: 2012-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors
Detailed Description: OBJECTIVES
Determine the safety tolerability and maximum tolerated dose MTD of CCI-779 in patients with advanced solid tumors part I who are not receiving anticonvulsant therapy Determine the safety tolerability and MTD in patients with recurrent gliomas or brain metastases part II who are receiving anticonvulsant therapy Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients
OUTLINE This is an open-label dose-escalation study
Part I Patients receive CCI-779 IV over 30 minutes on days 1-5 followed by a 9 day rest period Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
The maximum tolerated dose for part I is defined as the dose level at which 33 of patients experience dose limiting toxicity
Part II Patients receive the same treatment schedule as part I Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I At least 3 patients are entered at each dose level in part II
PROJECTED ACCRUAL Approximately 20 patients will be accrued for part I for this study within 8 months and 12 patients will be accrued for part II within 7 months