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| Sponsor: | Pediatric Brain Tumor Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00275002 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving O6-benzylguanine together with temozolomide works in treating young patients with recurrent or progressive gliomas or brain stem tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: O6-benzylguanine Drug: temozolomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of O6-Benzylguanine and Temozolomide in Pediatric Patients With Recurrent or Progressive High-Grade Gliomas and Recurrent or Progressive Brainstem Tumors |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (high-grade gliomas vs brain stem tumors).
Patients receive O6-benzylguanine IV over 1 hour followed by oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* high-grade glioma or brain stem tumor, including any of the following:
Recurrent or progressive disease after treatment with standard therapy
Bi-dimensionally measurable disease, defined as at least 1 lesion that can be measured in ≥ 2 dimensions
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Other
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family 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 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
| Houston, Texas, United States, 77030-2399 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Study Chair: | Katherine Warren, MD | NCI - Pediatric Oncology Branch |
| Investigator: | Sri Gururangan, MD | Duke University |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( James M. Boyett ) |
| Study ID Numbers: | CDR0000455561, PBTC-015, NCI-06-C-0089, NCI-P6692 |
| Study First Received: | January 10, 2006 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00275002 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent childhood brain stem glioma recurrent childhood brain tumor |
|
Disease Attributes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Brain Stem Neoplasms Central Nervous System Neoplasms Brain Diseases Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasms, Germ Cell and Embryonal Infratentorial Neoplasms O(6)-benzylguanine Glioma Alkylating Agents |
Nervous System Neoplasms Neoplasms by Histologic Type Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Temozolomide Pharmacologic Actions Recurrence Neuroectodermal Tumors Brain Neoplasms Neoplasms Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |