Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003712
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Brief Title:
CCI-779 in Treating Patients With Advanced Solid Tumors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1506 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |
| P30CA054174 | NIH | None | None |
| UTHSC-9785011303 | OTHER | None | None |
| SACI-IDD-98-02 | OTHER | None | None |
| W-AR-3066K1-100-US | OTHER | None | None |