Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

NCT00016354 | Completed Phase 1 Results DMC

• 5 other identifiers: J0072 CDR0000068625U01CA070095P30CA006973JHOC-J0072NCI-1351
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks (1 course of treatment for each subject)

Secondary Outcomes (3)

• Number of Patients With Adverse Events

  every 4 weeks

• Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU

  8 weeks

• Test for Antitumor Activity in Blood and Tissue

  baseline

Study Arms (1)

benzoylphenylurea

EXPERIMENTAL

Drug: benzoylphenylurea

Interventions

benzoylphenylurea DRUG

benzoylphenylurea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related Publications (2)

• Messersmith WA, Rudek MA, Baker SD, Zhao M, Collins C, Colevas AD, Donehower RC, Carducci MA, Wolff AC. Phase I study of continuous weekly dosing of dimethylamino benzoylphenylurea (BPU) in patients with solid tumours. Eur J Cancer. 2007 Jan;43(1):78-86. doi: 10.1016/j.ejca.2006.09.006. Epub 2006 Nov 3.

  PMID: 17084620 RESULT

• Messersmith WA, Baker SD, Donehower RC, et al.: Phase I study of continuous weekly dosing of dimethyl benzoylphenylurea (BPU) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-815, 2003.

  RESULT

Results Point of Contact

• Title: Dr. Antonio Wolff
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

awolff@jhmi.edu

410-614-4192

Study Officials

• Antonio C. Wolff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2006
• Last Updated: March 25, 2013
• Results First Posted: August 31, 2012

Record last verified: 2013-03

Locations

US (1)