Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor
Brief 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 oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.
Detailed description
OBJECTIVES: * Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression. * Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse. * Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. * Describe the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (medulloblastoma \[measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression\] vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor). Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.
Interventions
DRUGOxaliplatin
Sponsors
National Cancer Institute (NCI)
Pediatric Brain Tumor Consortium
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor * Recurrent or refractory disease * Measurable disease by radiography * Patients with positive cerebrospinal fluid cytology or linear leptomeningeal disease are eligible PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Karnofsky 50-100% OR * Lansky 50-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Hepatic * Bilirubin no greater than 1.5 times normal * ALT less than 2.5 times normal Renal * Creatinine no greater than 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by MUGA Pulmonary * No dyspnea at rest * No exercise intolerance * Pulse oximetry greater than 94% Other * No uncontrolled infection * No active graft-versus-host disease * No uncontrolled seizure disorders * Seizure disorders well controlled with anticonvulsants allowed * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior growth factors * At least 6 months since prior allogeneic stem cell transplantation * No concurrent colony-stimulating factors during the first course of study * No concurrent immunomodulating agents Chemotherapy * At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas) and recovered * No other concurrent anticancer chemotherapy Endocrine therapy * If concurrent corticosteroids necessary for intracranial pressure, must be on stable or decreasing dose for at least 1 week prior to study * No other concurrent corticosteroids Radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) to symptomatic metastatic sites * At least 3 months since prior craniospinal radiotherapy * No concurrent palliative radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * No other concurrent anticancer or experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression | — |
| Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT) | — |
| Pharmacokinetics of oxaliplatin in the serum and CSF | — |
Countries
United States
Outcome results
None listed