NCT Number: NCT00047177
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
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.
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Conditions
Age range
Up to 21 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
UCSF Comprehensive Cancer Center, San Francisco, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Pediatric Brain Tumor Consortium
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
Important dates
- Study start
- 2002
- Primary completion
- 2004
- Study completion
- 2007
- First posted
- Jan 27, 2003
- Registry last updated
- Oct 15, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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