Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00010205
Benzoylphenylurea in Treating Patients With Advanced Cancer
A Phase 1 study testing benzoylphenylurea and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- benzoylphenylurea and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- At least 2 weeks since steroids for CNS disease
- At least 4 weeks since prior radiotherapy and recovered
- Prior surgery allowed
- At least 2 weeks since antiseizure medications for CNS disease
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595
About this study
Official title: Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy
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
Read the detailed description
OBJECTIVES:
- Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy.
II. 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.
- Being tested
- benzoylphenylurea, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzoylphenylureaDrug
Also called BPU
Given orally
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (benzoylphenylurea) | Experimental | 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. Receives: Drug: benzoylphenylurea; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD) defined as the highest dose level where 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0
Measured: 8 weeks
DLT defined as grade 3 or worse non-hematologic and sustained (> 5 days) grade 3 hematologic toxicity or grade 4 hematologic toxicity of any duration, and the moderate toxicity is grade 2 toxicity as assessed by CTCAE version 3.0
Measured: 8 weeks
Pharmacokinetics of benzoylphenylurea
Relationships between drug exposure and toxicity, efficacy, and biological endpoints will be explored using univariate and multivariate analysis techniques.
Measured: At baseline, at 0.5, 1.0, 1.5, 2, 4, 6, 8, 24, 48, 72, and 96 hours (weeks 1 and 6)
Secondary outcomes (2)
Response (complete and partial response) rate
Response rate will be evaluated for all patients with measurable disease and will be obtained by dividing the total number of responses by all patients with measurable disease and reported with 95% confidence intervals.
Measured: Up to 7 years
Survival
The median and landmark survivals will be estimated utilizing the Kaplan- Meier method.
Measured: From the date of first treatment until death or last follow-up, assessed up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2000
- Primary completionJan 2007
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Martin Edelman, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010205
- Sponsor's protocol ID
- NCI-2012-02375
- Other IDs
- UMGCC 0038, U01CA069854, CDR0000068455
- Status last verified
- Jan 2013
- First submitted
- 2 Feb 2001
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Of Benzoylphenylurea (NSC#639829) In Advanced Malignancy
- ClinicalTrials.gov ID
- NCT00010205
- Acronym / sponsor ID
- NCI-2012-02375
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2000
- Primary completion
- Jan 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
- Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy.
II. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (benzoylphenylurea) | Experimental | Drug: benzoylphenylurea, Other: pharmacological studyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Histologically confirmed malignancy
- Brain metastases allowed provided 1 of the following criteria is met:
- Performance status - ECOG 0-2
- More than 12 weeks
- WBC at least 3,000/mm^3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzoylphenylureaAlso: BPUGiven orally | Drug | Treatment (benzoylphenylurea) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (benzoylphenylurea) |
Primary outcome
Maximum-tolerated dose (MTD) defined as the highest dose level where 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0
Time frame: 8 weeks
DLT defined as grade 3 or worse non-hematologic and sustained (> 5 days) grade 3 hematologic toxicity or grade 4 hematologic toxicity of any duration, and the moderate toxicity is grade 2 toxicity as assessed by CTCAE version 3.0
Time frame: 8 weeks
Pharmacokinetics of benzoylphenylurea
Time frame: At baseline, at 0.5, 1.0, 1.5, 2, 4, 6, 8, 24, 48, 72, and 96 hours (weeks 1 and 6)
Relationships between drug exposure and toxicity, efficacy, and biological endpoints will be explored using univariate and multivariate analysis techniques.
2 secondary outcomes
Response (complete and partial response) rate
Time frame: Up to 7 years
Survival
Time frame: From the date of first treatment until death or last follow-up, assessed up to 7 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Edelman principal investigator
University of Maryland Greenebaum Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing benzoylphenylurea and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum-tolerated dose (MTD) defined as the highest dose level where 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0 (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.