Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Pediatric Brain Tumor Consortium

Maryam Fouladi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00047177
Information obtained from ClinicalTrials.gov on December 14, 2011

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