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Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
This study has been completed.
Study NCT00047177   Information provided by Pediatric Brain Tumor Consortium
First Received: October 3, 2002   Last Updated: October 14, 2009   History of Changes

October 3, 2002
October 14, 2009
October 2002
August 2004   (final data collection date for primary outcome measure)
  • Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression [ Designated as safety issue: No ]
  • Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00047177 on ClinicalTrials.gov Archive Site
  • Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT) [ Designated as safety issue: No ]
  • Pharmacokinetics of oxaliplatin in the serum and CSF [ Designated as safety issue: No ]
Same as current
 
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors

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.

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.

Phase II
Interventional
Treatment, Open Label, Efficacy Study
Brain and Central Nervous System Tumors
Drug: Oxaliplatin
 
Fouladi M, Blaney SM, Poussaint TY, Freeman BB 3rd, McLendon R, Fuller C, Adesina AM, Hancock ML, Danks MK, Stewart C, Boyett JM, Gajjar A. Phase II study of oxaliplatin in children with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumors, and atypical teratoid rhabdoid tumors: a pediatric brain tumor consortium study. Cancer. 2006 Nov 1;107(9):2291-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
43
July 2007
August 2004   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047177
James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium
CDR0000257562, PBTC-010
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Study Chair: Maryam Fouladi, MD Children's Hospital Medical Center, Cincinnati
Pediatric Brain Tumor Consortium
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP