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

Sponsor:	Pediatric Brain Tumor Consortium
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:	NCT00047177

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 refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: Oxaliplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Efficacy Study
Official Title:	A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by Pediatric Brain Tumor Consortium:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	43
Study Start Date:	October 2002
Study Completion Date:	July 2007
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047177

Locations

United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Texas Children's Cancer Center
Houston, Texas, United States, 77030-2399
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Pediatric Brain Tumor Consortium

National Cancer Institute (NCI)

Investigators

Study Chair:

Maryam Fouladi, MD

Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Pediatric Brain Tumor Consortium ( James M. Boyett/PBTC Operations and Biostatistics Center Executive Director )
Study ID Numbers:	CDR0000257562, PBTC-010
Study First Received:	October 3, 2002
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00047177 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pediatric Brain Tumor Consortium:

recurrent childhood medulloblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood ependymoma
childhood atypical teratoid/rhabdoid tumor

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Rhabdoid Tumor
Neoplasms by Histologic Type
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Pharmacologic Actions
Neuroectodermal Tumors
Oxaliplatin

Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Complex and Mixed
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009