Brain and Central Nervous System TumorsPhase 2NCT00002749
Carboplatin in Patients With Progressive Gliomas
A Phase 2 study testing carboplatin in people with Brain and Central Nervous System Tumors, run by Duke University at 2 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with progressive glioma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- carboplatin
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 1993to Mar 2000
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed primary intracranial low-grade glioma (i.e., astrocytoma or oligodendroglioma) No more than 2 years since tissue diagnosis Biopsy not required for intrinsic chiasmatic mass or tumor infiltration along the posterior optic tracts Evidence of progressive disease by at least one of the following: Papilledema or other clinical sign of increased intracranial pressure Documented change in neuroimaging studies, e.g.: Hydrocephalus 25% increase in product of maximum perpendicular diameters of tumor The following are required in patients with optic pathway gliomas: Progressive loss of vision documented by an ophthalmologist, i.e.: Doubling of octaves (e.g., 20/20 to 20/40 or 20/40 to 20/80) on 2 successive visits Loss of visual acuity not explainable by other causes, e.g., media abnormalities or amblyopia Greater than 3 mm increase in proptosis At least 2 mm increase in diameter of optic nerve on neuroimaging Increase in distribution of tumor involving the optic tracts or optic radiations demonstrated by CT or MRI using T1 (with or without contrast) or T2 imaging
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: At least 12 weeks Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin less than 1.5 times normal ALT less than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Other: Negative pregnancy test required of fertile women Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: At least 12 weeks since radiotherapy (4 weeks since other therapy) and recovered Prior chemotherapy allowed with subsequent disease progression
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: PHASE II STUDY OF CARBOPLATIN (CBDCA) IN THE TREATMENT OF CHILDREN AND ADULTS WITH PROGRESSIVE LOW GRADE GLIOMAS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with progressive glioma.
Read the detailed description
OBJECTIVES: I. Assess the response to carboplatin (CBDCA) in patients with progressive low-grade gliomas. II. Assess the activity of CBDCA in stabilizing the growth of these tumors.
OUTLINE: Single-Agent Chemotherapy. Carboplatin, CBDCA, NSC-241240.
PROJECTED ACCRUAL: A total of 25 evaluable patients will be entered if there is at least 1 response in the first 9 patients.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- carboplatin
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent adult brain tumor, adult brain stem glioma, childhood oligodendroglioma, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood visual pathway glioma, recurrent childhood visual pathway glioma, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, adult anaplastic astrocytoma, adult oligodendroglioma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Oligodendroglioma, Optic Nerve Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2004 (estimated)
- Study startFeb 1993
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Henry S. Friedman, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002749
- Sponsor's protocol ID
- CDR0000064682
- Other IDs
- DUMC-0157-00-1R7, DUMC-0137-99-1R6, DUMC-081-96-1R3, DUMC-115-97-1R4, DUMC-118-98-1R5, NCI-V96-0868
- Status last verified
- Oct 2009
- First submitted
- 1 Nov 1999
- Last updated
- 14 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY OF CARBOPLATIN (CBDCA) IN THE TREATMENT OF CHILDREN AND ADULTS WITH PROGRESSIVE LOW GRADE GLIOMAS
- ClinicalTrials.gov ID
- NCT00002749
- Acronym / sponsor ID
- CDR0000064682
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent adult brain tumor, adult brain stem glioma, childhood oligodendroglioma, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood visual pathway glioma, recurrent childhood visual pathway glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 1993
- Study completion
- Mar 2000 (actual)
- First posted
- 11 Aug 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with progressive glioma.
Detailed description
OBJECTIVES: I. Assess the response to carboplatin (CBDCA) in patients with progressive low-grade gliomas. II. Assess the activity of CBDCA in stabilizing the growth of these tumors.
OUTLINE: Single-Agent Chemotherapy. Carboplatin, CBDCA, NSC-241240.
PROJECTED ACCRUAL: A total of 25 evaluable patients will be entered if there is at least 1 response in the first 9 patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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.
Henry S. Friedman, MD study chair
Duke University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin in people with Brain and Central Nervous System Tumors, run by Duke University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 14 Oct 2009.