Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor