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Benzoylphenylurea in Treating Patients With Advanced Cancer
This study has been completed.
First Received: February 2, 2001   Last Updated: May 23, 2008   History of Changes
Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00010205
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: benzoylphenylurea
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: March 2001
Detailed Description:

OBJECTIVES:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010205

Locations
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000068455, MSGCC-0038, NCI-1352
Study First Received: February 2, 2001
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00010205     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on May 06, 2009