A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
N/A
21 Years
Both
Brain and Central Nervous System Tumors
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 Philadelphia | Philadelphia, Pennsylvania 19104 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Texas Children's Cancer Center | Houston, Texas 77030-2399 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
