Benzoylphenylurea in Treating Patients With Advanced Cancer
Stopped early · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Key facts
- Study ID
- NCT00010205
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2000-12-01
- Last updated by the study team
- 2013-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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