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OpenTrials
Completed

NCT Number: NCT00047177

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin

Drug

Primary outcomes

  1. Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression

  2. Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse

Secondary outcomes

  1. Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)

  2. Pharmacokinetics of oxaliplatin in the serum and CSF

Sponsors and collaborators

Lead sponsor

Pediatric Brain Tumor Consortium

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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