Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Benzoylphenylurea in Treating Patients With Advanced Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI MSGCC-0038 NCI-1352, NCT00010205, 1352

Objectives

1. Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy.
2. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Prior immunotherapy allowed
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

Endocrine therapy:

• See Disease Characteristics
• At least 2 weeks since steroids for CNS disease

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Prior surgery allowed

Other:

• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin normal
• SGOT/SGPT no greater than 2.5 times upper limit of normal
• Albumin at least 3.0 mg/dL

Renal:

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Other:

• 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

Expected Enrollment

A total of 3-30 patients will be accrued for this study.

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.

Edelman MJ, Bauer KS, Meiller T, et al.: Phase I, pharmacokinetic (PK) and pharmacodynamic study of benzoylphenylurea (BPU, NSC 639829), a novel antitubulin agent. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-550, 2003.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Martin Edelman, MD, Protocol chair		Ph: 410-328-2703; 800-888-8823 Email: medelman@umm.edu

Registry Information
Official Title		Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy
Trial Start Date		2001-03-02
Registered in ClinicalTrials.gov		NCT00010205
Date Submitted to PDQ		2000-12-19
Information Last Verified		2006-11-29
NCI Grant/Contract Number		CA69854

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