Carboplatin in Patients With Progressive Gliomas

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002749
• Date of registration: 01/11/1999
• Primary sponsor: Duke University
• Public title: Carboplatin in Patients With Progressive Gliomas
• Scientific title: PHASE II STUDY OF CARBOPLATIN (CBDCA) IN THE TREATMENT OF CHILDREN AND ADULTS WITH PROGRESSIVE LOW GRADE GLIOMAS
• Date of first enrolment: February 1993
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002749
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Henry S. Friedman, MD
• Affiliation: Duke University

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Brain and Central Nervous System Tumors

Intervention(s)

Drug: carboplatin

Secondary ID(s)

CDR0000064682

DUMC-0137-99-1R6

DUMC-0157-00-1R7

DUMC-081-96-1R3

DUMC-115-97-1R4

DUMC-118-98-1R5

NCI-V96-0868

Source(s) of Monetary Support

Please refer to primary and secondary sponsors