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.

Condition	Treatment or Intervention	Phase
recurrent childhood brain stem glioma recurrent childhood visual pathway glioma recurrent childhood cerebral astrocytoma recurrent childhood cerebellar astrocytoma adult well-differentiated mildly and moderately anaplastic astrocytoma recurrent adult brain tumor untreated childhood brain stem glioma untreated childhood visual pathway glioma adult well-differentiated oligodendroglioma low-grade childhood cerebral astrocytoma adult brain stem glioma untreated childhood cerebellar astrocytoma Childhood Oligodendroglioma	Drug: carboplatin	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• At least 12 weeks since radiotherapy (4 weeks since other therapy) and recovered; Prior chemotherapy allowed with subsequent disease progression

--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

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Canada, Quebec
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada

Study chairs or principal investigators

Henry S. Friedman,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000064682; DUMC-0157-00-1R7; NCI-V96-0868; DUMC-0137-99-1R6; DUMC-081-96-1R3; DUMC-115-97-1R4; DUMC-118-98-1R5
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002749
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08