Benzoylphenylurea in Treating Patients With Advanced Cancer

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00010205
First received: February 2, 2001
Last updated: January 24, 2013
Last verified: January 2013

February 2, 2001
January 24, 2013
December 2000
January 2007   (final data collection date for primary outcome measure)
  • Maximum-tolerated dose (MTD) defined as the highest dose level where 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • DLT defined as grade 3 or worse non-hematologic and sustained (> 5 days) grade 3 hematologic toxicity or grade 4 hematologic toxicity of any duration, and the moderate toxicity is grade 2 toxicity as assessed by CTCAE version 3.0 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of benzoylphenylurea [ Time Frame: At baseline, at 0.5, 1.0, 1.5, 2, 4, 6, 8, 24, 48, 72, and 96 hours (weeks 1 and 6) ] [ Designated as safety issue: No ]
    Relationships between drug exposure and toxicity, efficacy, and biological endpoints will be explored using univariate and multivariate analysis techniques.
Not Provided
Complete list of historical versions of study NCT00010205 on ClinicalTrials.gov Archive Site
  • Response (complete and partial response) rate [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Response rate will be evaluated for all patients with measurable disease and will be obtained by dividing the total number of responses by all patients with measurable disease and reported with 95% confidence intervals.
  • Survival [ Time Frame: From the date of first treatment until death or last follow-up, assessed up to 7 years ] [ Designated as safety issue: No ]
    The median and landmark survivals will be estimated utilizing the Kaplan- Meier method.
Not Provided
Not Provided
Not Provided
 
Benzoylphenylurea in Treating Patients With Advanced Cancer
Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy

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

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: benzoylphenylurea
    Given orally
    Other Name: BPU
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Experimental: 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.
Interventions:
  • Drug: benzoylphenylurea
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
Not Provided
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010205
NCI-2012-02375, UMGCC 0038, U01CA069854, CDR0000068455
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Martin Edelman University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
January 2013

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