Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023816
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-09-13
Brief Title:
Carbendazim in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2001-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors or lymphoma
PURPOSE Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of carbendazim in patients with advanced solid tumors or lymphoma II Determine the qualitative and quantitative toxic effects of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine the recommended phase II dose of this drug V Determine any antitumor effects of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients receive oral carbendazim 2-3 times daily 5 days a week for 3-4 weeks Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of carbendazim until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 30-60 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients receive oral carbendazim 2-3 times daily 5 days a week for 3-4 weeks Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of carbendazim until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 30-60 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 |
|---|---|---|---|
| UCLA-0002007 | None | None | None |
| ILEX-FB-642-103-A4 | None | None | None |
| NCI-G01-2006 | None | None | None |