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Benzoylphenylurea in Treating Patients With Advanced Solid Tumors



Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AntonioWolff,  Study Chair,  Sidney Kimmel Cancer Center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore,  Maryland,  21231-2410
United States
Recruiting Antonio  Wolff 410-614-4192


Additional Information:
Study ID Numbers:  CDR0000068625;  JHOC-J0072,NCI-1351
Study Start Date: 
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016354

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer

2. KRN5500 in Treating Patients With Solid Tumors

3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

4. SR-45023A in Treating Patients With Advanced Solid Tumors

5. Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C

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