Brain and Central Nervous System Tumors
Conditions
Keywords
untreated childhood brain stem glioma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed, diffuse, intrinsic brain stem glioma. * Determine the toxicity of this regimen in these patients. * Assess the antitumor activity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of paclitaxel. Patients receive induction therapy comprising paclitaxel intravenously (IV) over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks. Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study within 12-18 months.
Interventions
DRUGpaclitaxel
RADIATIONradiation therapy
Sponsors
Children's Hospital of Philadelphia
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and magnetic resonance imaging (MRI) * Histologic verification not required * Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed * Contiguous involvement of the thalamus or upper cervical cord allowed PATIENT CHARACTERISTICS: Age: * 3 to 21 at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin greater than 10.0 g/dL Hepatic: * Bilirubin less than 1.5 times normal * serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 2.5 times normal Renal: * Creatinine less than 1.5 times normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No other concurrent anticancer chemotherapy Endocrine therapy: * Concurrent corticosteroid therapy for increased intracranial pressure allowed Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy * Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed
Countries
United States
Outcome results
None listed