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Benzoylphenylurea in Treating Patients With Advanced Cancer
This study has been completed.
Study NCT00010205   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: May 23, 2008   History of Changes

February 2, 2001
May 23, 2008
March 2001
 
 
 
Complete list of historical versions of study NCT00010205 on ClinicalTrials.gov Archive Site
 
 
 
Benzoylphenylurea in Treating Patients With Advanced Cancer
Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: benzoylphenylurea
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010205
 
CDR0000068455, MSGCC-0038, NCI-1352
University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP