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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047177
• Other study ID #: CDR0000257562
• Secondary ID: PBTC-010
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2002
• Last updated: October 14, 2009
• Start date: October 2002
• Est. completion date: July 2007

Study information

• Verified date: October 2009
• Source: Pediatric Brain Tumor Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2007
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Medulloblastoma
• Nervous System Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Rhabdoid Tumor

Intervention

Drug:
• Oxaliplatin

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Children's Memorial Hospital - Chicago	Chicago	Illinois
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Texas Children's Cancer Center	Houston	Texas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pediatric Brain Tumor Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ne — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression			No
Primary	Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse			No
Secondary	Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)			No
Secondary	Pharmacokinetics of oxaliplatin in the serum and CSF			No