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

This study is no longer recruiting patients.

Sponsors and Collaborators: Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 refractorymedulloblastoma, supratentorialprimitive neuroectodermal or atypical teratoid rhabdoid tumor.

Condition Treatment or Intervention Phase
recurrent childhood medulloblastoma
recurrent childhood supratentorial primitive neuroectodermal tumors
recurrent childhood ependymoma
childhood rhabdoid tumor of the central nervous system
 Drug: oxaliplatin
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Oxaliplatin in Pediatric Patients With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Further Study Details: 

OBJECTIVES:

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.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.

Eligibility

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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


Location Information


California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States

Illinois
      Children's Memorial Hospital - Chicago, Chicago,  Illinois,  60614,  United States

Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104-4318,  United States

      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States

Tennessee
      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States

Texas
      Texas Children's Cancer Center, Houston,  Texas,  77030-2399,  United States

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States

Study chairs or principal investigators

Maryam Fouladi, MD,  Study Chair,  St. Jude Children's Research Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000257562; PBTC-010
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00047177
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005