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Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Martin Edelman

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02375

NCT ID:

NCT00010205

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201