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


Phase 2
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression

Safety Issue:

No

Principal Investigator

Maryam Fouladi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000257562

NCT ID:

NCT00047177

Start Date:

October 2002

Completion Date:

July 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood medulloblastoma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood ependymoma
  • childhood atypical teratoid/rhabdoid tumor
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Rhabdoid Tumor

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Texas Children's Cancer CenterHouston, Texas  77030-2399
UCSF Comprehensive Cancer CenterSan Francisco, California  94115