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Sponsors and Collaborators: |
University of Maryland Greenebaum Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010205 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: benzoylphenylurea |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy |
Estimated Enrollment: | 30 |
Study Start Date: | March 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy
Brain metastases allowed provided 1 of the following criteria is met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 |
Study Chair: | Martin J. Edelman, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000068455, MSGCC-0038, NCI-1352 |
Study First Received: | February 2, 2001 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00010205 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |