benzoylphenylurea in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: 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.

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.

Eligibility criteria:
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

Keywords: unspecified adult solid tumor, protocol specific