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Sponsors and Collaborators: |
Pediatric Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047177 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Oxaliplatin in Children With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors |
Study Start Date: | October 2002 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No uncontrolled seizure disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
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 |
Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | CDR0000257562, PBTC-010 |
Study First Received: | October 3, 2002 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00047177 |
Health Authority: | United States: Federal Government |
recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood ependymoma childhood atypical teratoid/rhabdoid tumor |
Neuroectodermal Tumors, Primitive Rhabdoid Tumor Central Nervous System Neoplasms Ependymoma Recurrence Rhabdoid tumor Neuroectodermal Tumors |
Oxaliplatin Neoplasms, Germ Cell and Embryonal Medulloblastoma Neuroepithelioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions Neoplasms, Complex and Mixed |