Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016354
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2001-05-06
Brief Title:
Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Study of Continuous Weekly Dosing of Dimethyl Benzoylphenylurea BPU in Patients With Solid Tumors Not Responding to Conventional Therapy
Status:
COMPLETED
Status Verified Date:
2013-03
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 benzoylphenylurea in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors
Evaluate the acute and chronic toxicity profile of this regimen in these patients
Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral benzoylphenylurea BPU once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity Once the MTD is determined 12 additional patients are accrued and treated with BPU as above to confirm the MTD
Patients are followed for 30 days
PROJECTED ACCRUAL Approximately 18-24 patients will be accrued for this study
Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors
Evaluate the acute and chronic toxicity profile of this regimen in these patients
Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral benzoylphenylurea BPU once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity Once the MTD is determined 12 additional patients are accrued and treated with BPU as above to confirm the MTD
Patients are followed for 30 days
PROJECTED ACCRUAL Approximately 18-24 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 |
|---|---|---|---|
| NCI-1351 | OTHER_GRANT | National Cancer Institute | httpsreporternihgovquickSearchP30CA006973 |
| U01CA070095 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0072 | OTHER | None | None |