Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Continuous Weekly Dosing of Dimethyl Benzoylphenylurea (BPU) in Patients With Solid Tumors Not Responding to Conventional Therapy|
- Determine Maximum Tolerated Dose of BPU [ Time Frame: 4 weeks (1 course of treatment for each subject) ] [ Designated as safety issue: Yes ]Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.
- Number of Patients With Adverse Events [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
- Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Test for Antitumor Activity in Blood and Tissue [ Time Frame: baseline ] [ Designated as safety issue: No ]
|Study Start Date:||March 2001|
|Study Completion Date:||September 2006|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016354
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Antonio C. Wolff, MD||Sidney Kimmel Comprehensive Cancer Center|