Expired Study
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Baltimore, Maryland 21231


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors. - Evaluate the acute and chronic toxicity profile of this regimen in these patients. - Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients. - Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral benzoylphenylurea (BPU) once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated with BPU as above to confirm the MTD. Patients are followed for 30 days. PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Histologically confirmed malignancy - Metastatic or unresectable - No effective standard curative or palliative measures exist - No known CNS or brain metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT normal Renal: - Creatinine normal - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No uncontrolled ventricular arrhythmia - No myocardial infarction within the past 3 months - No superior vena cava syndrome Neurologic: - No grade 1 or greater peripheral neuropathy - No uncontrolled major seizure disorder - No spinal cord compression Other: - No active serious infection requiring IV antibiotics - No concurrent uncontrolled illness - No concurrent unstable or serious medical condition - No chronic diarrhea or malabsorption - No history of allergic reactions to compounds similar in chemical or biological composition to benzoylphenylurea - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy - No concurrent growth factors during first 2 courses of study - Concurrent epoetin alfa allowed Chemotherapy: - At least 28 days since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy Radiotherapy: - At least 28 days since prior large-field radiotherapy - Prior palliative radiotherapy for painful bone metastases allowed - No concurrent radiotherapy, including palliative or whole-brain radiotherapy for CNS disease Surgery: - At least 28 days since prior major surgery Other: - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies for the malignancy - No other concurrent investigational agents - Concurrent bisphosphonates allowed if bone metastases are not only site of measurable or evaluable disease



Primary Contact:

Study Chair
Antonio C. Wolff, MD
Sidney Kimmel Comprehensive Cancer Center

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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