Benzoylphenylurea in Treating Patients With Advanced Cancer

NCT ID: NCT00010205

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31

Brief Summary

This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description

OBJECTIVES:

I. Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy.

II. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral benzoylphenylurea weekly for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of benzoylphenylurea 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: A total of 3-30 patients will be accrued for this study.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (benzoylphenylurea)

Patients receive oral benzoylphenylurea weekly for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of benzoylphenylurea 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.

Group Type: EXPERIMENTAL

benzoylphenylurea

Intervention Type: DRUG

Given orally

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

benzoylphenylurea

Given orally

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

BPU; pharmacological studies

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed malignancy

• Metastatic or unresectable
• No standard curative or palliative measures exist or are ineffective
• Brain metastases allowed provided 1 of the following criteria is met:

• Lesions were previously treated with surgery, radiotherapy, or chemotherapy AND are currently asymptomatic AND no steroid therapy or antiseizure medication within the past 2 weeks
• Untreated, asymptomatic metastases AND no requirement for steroid therapy or antiseizure medication
• Performance status - ECOG 0-2
• More than 12 weeks
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin normal
• SGOT/SGPT no greater than 2.5 times upper limit of normal
• Albumin at least 3.0 mg/dL
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• No prior allergic reactions to compounds of similar chemical or biologic composition to benzoylphenylurea
• No neuropathy greater than grade 1
• No other uncontrolled medical or psychiatric illness that would preclude study compliance
• No ongoing or active infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Prior immunotherapy allowed
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
• At least 2 weeks since steroids for CNS disease
• At least 4 weeks since prior radiotherapy and recovered
• Prior surgery allowed
• At least 2 weeks since antiseizure medications for CNS disease
• More than 7 days since prior CYP3A4 or CYP2D6 inhibitors
• More than 7 days since prior CYP3A4 inducers
• No concurrent CYP3A4 or CYP2D6 inhibitors
• No concurrent CYP3A4 inducers
• No other concurrent investigational agents
• No concurrent combination anti-retroviral therapy for HIV

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Edelman

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Locations

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

UMGCC 0038

Identifier Type: -

Identifier Source: secondary_id

U01CA069854

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068455

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02375

Identifier Type: -

Identifier Source: org_study_id