Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 21 and under NCI PBTC-010 NCT00047177

Objectives

1. Determine the objective response rate in pediatric patients with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor treated with oxaliplatin.
2. Determine the objective response rate (complete and partial response) in patients with recurrent or progressive medulloblastoma at second or later relapse treated with this drug.
3. Determine the pharmacokinetics of this drug in these patients.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³ (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

Expected Enrollment

A total of 65 patients will be accrued for this study within 1.5-2.8 years.

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.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Fouladi M, Blaney SM, Poussaint TY, et al.: 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 107 (9): 2291-7, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Pediatric Brain Tumor Consortium

Maryam Fouladi, MD, Protocol chair		Ph: 513-803-0721; 800-344-2462

Registry Information
Official Title		A Phase II Study of Oxaliplatin in Children with Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
Trial Start Date		2002-10-07
Registered in ClinicalTrials.gov		NCT00047177
Date Submitted to PDQ		2002-08-15
Information Last Verified		2003-12-10
NCI Grant/Contract Number		CA81457

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