Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003708
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Brief Title:
Chemotherapy 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 Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies
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 temozolomide in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the safety tolerability maximum tolerated dose and dose limiting toxicity of temozolomide in patients with advanced solid malignancies II Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients III Determine antitumor activity of temozolomide in these patients
OUTLINE This is an open label dose escalation study Patients receive oral temozolomide on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at escalating doses of temozolomide The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT during courses 1 or 2 with at least 2 patients experiencing DLT at the next higher dose level
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is an open label dose escalation study Patients receive oral temozolomide on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated at escalating doses of temozolomide The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT during courses 1 or 2 with at least 2 patients experiencing DLT at the next higher dose level
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA054174 | NIH | None | None |
| UTHSC-9785011336 | OTHER | None | None |
| SACI-IDD-98-09 | OTHER | None | None |
| SPRI-C98-247 | OTHER | None | None |
| NCI-V98-1502 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |