Benzoylphenylurea in Treating Patients With Advanced Cancer

NCT00010205 | Terminated Phase 1

• 4 other identifiers: NCI-2012-02375UMGCC 0038U01CA069854CDR0000068455
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• 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

  8 weeks

• 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

  8 weeks

• Pharmacokinetics of benzoylphenylurea

  Relationships between drug exposure and toxicity, efficacy, and biological endpoints will be explored using univariate and multivariate analysis techniques.

  At baseline, at 0.5, 1.0, 1.5, 2, 4, 6, 8, 24, 48, 72, and 96 hours (weeks 1 and 6)

Secondary Outcomes (2)

• Response (complete and partial response) rate

  Up to 7 years

• Survival

  From the date of first treatment until death or last follow-up, assessed up to 7 years

Study Arms (1)

Treatment (benzoylphenylurea)

EXPERIMENTAL

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.

Drug: benzoylphenylurea; Other: pharmacological study

Interventions

benzoylphenylurea DRUG

Given orally

Also known as: BPU

Treatment (benzoylphenylurea)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (benzoylphenylurea)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

Location

Study Officials

• Martin Edelman

  University of Maryland Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Primary Completion: January 1, 2007
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)