Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003021
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
1999-11-01
Brief Title:
Bizelesin in Treating Patients With Advanced Cancer
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 Trial of Bizelesin NSC 615291 Using a Single Bolus Infusion Given Every Twenty-eight 28 Days in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2012-11
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 bizelesin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of bizelesin in patients with advanced cancer II Determine the qualitative and quantitative toxic effects of this therapy in these patients III Determine the pharmacokinetics of this therapy in these patients IV Determine the recommended dose of this drug for phase II trials V Determine the antitumor effects of this therapy in these patients
OUTLINE This is a dose-escalation study Patients receive bizelesin IV on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive bizelesin IV on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 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 |
|---|---|---|---|
| SACI-IDD-93-45 | None | None | None |
| UTHSC-IDD-93-45 | None | None | None |
| NCI-T93-0166 | None | None | None |