Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: benzoylphenylurea

• Registration Number: NCT00016354
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2001-05-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-08
• Study Completion: 2006-09
• Results First Submitted: 2012-06-11
• Results First Submitted QC: 2012-07-27
• Results First Posted: 2012-08-31
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
benzoylphenylurea	benzoylphenylurea	-

Primary Outcome Measures

Name	Time	Method
Determine Maximum Tolerated Dose of BPU	4 weeks (1 course of treatment for each subject)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events	every 4 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU	8 weeks
Test for Antitumor Activity in Blood and Tissue	baseline

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States