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Home > "B" Clinical Trials Conditions > Benzoylphenylurea in Treating Patients With Advanced Cancer  Benzoylphenylurea in Treating Patients With Advanced Cancer
Benzoylphenylurea in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Maryland Greenebaum 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 cancer.
Details: OBJECTIVES: - Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy. - 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.
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 standard curative or palliative measures exist or are ineffective - No brain metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal - Albumin at least 3.0 mg/dL Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Other: - 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 CONCURRENT THERAPY: Biologic therapy: - Prior immunotherapy allowed - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Prior surgery allowed Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinEdelman, Study Chair, University of Maryland Greenebaum Cancer Center
Veterans Affairs Medical Center - Baltimore *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Additional Information:
Study ID Numbers: CDR0000068455; NCI-1352,MSGCC-0038
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010205
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
2. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
3. Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
5. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Benzoylphenylurea in Treating Patients With Advanced Cancer
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