A Phase 1 interventional study of benzoylphenylurea in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-25.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1, Interventional, and Treatment
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed malignancy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Drug: benzoylphenylurea
Determine Maximum Tolerated Dose of BPU
Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays \>2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting \<5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.
Time frame: 4 weeks (1 course of treatment for each subject)
Number of Patients With Adverse Events
Time frame: every 4 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU
Time frame: 8 weeks
Test for Antitumor Activity in Blood and Tissue
Time frame: baseline
Nineteen patients were enrolled between August 2001 and July 2004 at Johns Hopkins.
| Milestone | Benzoylphenylurea 5 mg | Benzoylphenylurea 10 mg | Benzoylphenylurea 20 mg | Benzoylphenylurea 40 mg | Benzoylphenylurea 80 mg | Benzoylphenylurea 160 mg | Benzoylphenylurea 320 mg | Benzoylphenylurea Dose Level of 150 mg |
|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 1 | 1 | 6 | 7 |
| Completed | 1 | 1 | 1 | 1 | 1 | 1 | 6 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays \>2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting \<5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.
| milligrams (mg) | Benzoylphenylurea |
|---|---|
| Determine Maximum Tolerated Dose of BPU | 150 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over every 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benzoylphenylurea | — | 1/19 (5.3%) | 19/19 (100%) |
| Event | Benzoylphenylurea |
|---|---|
| Neutropenic feverInfections and infestations | 1/19 |
| Event | Benzoylphenylurea |
|---|---|
| Anemia (Hemoglobin)Blood and lymphatic system disorders | 3/19 |
| FatigueGeneral disorders | 3/19 |
| NauseaGastrointestinal disorders | 3/19 |
| Thrombocytopenia (Platelets)Blood and lymphatic system disorders | 2/19 |
| HeadacheGeneral disorders | 2/19 |
| DiarrheaGastrointestinal disorders | 2/19 |
| VomitingGastrointestinal disorders | 1/19 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/19 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 1/19 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/19 |
| Age, Categorical(Participants) | Benzoylphenylurea |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | Benzoylphenylurea |
|---|---|
| Female | 8 |
| Male | 11 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins