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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Pediatric Brain Tumor Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • Children's National Medical Center
  • Children's Memorial Hospital - Chicago
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Duke Comprehensive Cancer Center
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • St. Jude Children's Research Hospital
  • Texas Children's Cancer Center
  • Children's Hospital and Regional Medical Center - Seattle

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 3, 2002
Last Updated
October 14, 2009
Sponsor
Pediatric Brain Tumor Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00047177
Brief Title
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Official Title
A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pediatric Brain Tumor Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression
Title
Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse
Secondary Outcome Measure Information:
Title
Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)
Title
Pharmacokinetics of oxaliplatin in the serum and CSF

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Fouladi, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
Facility Name
Texas Children's Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17019740
Citation
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. doi: 10.1002/cncr.22241.
Results Reference
result

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

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