Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
This study has been completed.
Sponsor:
Pediatric Brain Tumor Consortium
Collaborator:
Information provided by:
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT00047177
First received: October 3, 2002
Last updated: October 14, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: Oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors |
Resource links provided by NLM:
Further study details as provided by Pediatric Brain Tumor Consortium:
Primary Outcome Measures:
- Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression [ Designated as safety issue: No ]
- Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT) [ Designated as safety issue: No ]
- Pharmacokinetics of oxaliplatin in the serum and CSF [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | October 2002 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047177
Locations
| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States, 77030-2399 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
Investigators
| Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
More Information
Additional Information:
Publications:
| Responsible Party: | James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00047177 History of Changes |
| Other Study ID Numbers: | CDR0000257562, PBTC-010 |
| Study First Received: | October 3, 2002 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pediatric Brain Tumor Consortium:
|
recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood ependymoma childhood atypical teratoid/rhabdoid tumor |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Rhabdoid Tumor Glioma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Neoplasms, Complex and Mixed Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013