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

Sponsor

Pediatric Brain Tumor Consortium (Other)

Overall Status

Completed

CT.gov ID

NCT00047177

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: Oxaliplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
2	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
3	Children's Memorial Hospital - Chicago	Chicago	Illinois	United States	60614
4	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4318
7	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
8	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794
9	Texas Children's Cancer Center	Houston	Texas	United States	77030-2399
10	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105