- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002749
Carboplatin in Patients With Progressive Gliomas
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Henry S. Friedman, MD, Duke University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated childhood brain stem glioma
- recurrent adult brain tumor
- adult anaplastic astrocytoma
- adult brain stem glioma
- adult oligodendroglioma
- untreated childhood cerebellar astrocytoma
- childhood oligodendroglioma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood brain stem glioma
- childhood low-grade cerebral astrocytoma
- untreated childhood visual pathway glioma
- recurrent childhood visual pathway glioma
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Antineoplastic Agents
- Carboplatin
Other Study ID Numbers
- CDR0000064682
- DUMC-0157-00-1R7
- DUMC-0137-99-1R6
- DUMC-081-96-1R3
- DUMC-115-97-1R4
- DUMC-118-98-1R5
- NCI-V96-0868
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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