Benzoylphenylurea in Treating Patients With Advanced Cancer

National Cancer Institute (NCI)

Status and phase

Terminated

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Other: pharmacological study

Drug: benzoylphenylurea

Study type

Interventional

Funder types

NIH

Identifiers

NCT00010205

NCI-2012-02375

UMGCC 0038

CDR0000068455 (Registry Identifier)

U01CA069854 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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