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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: | NCT00275002 |
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 |
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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.
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
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 |
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 |
Brain Stem Neoplasms Central Nervous System Diseases Brain Tumor, Childhood Central Nervous System Neoplasms Brain Diseases Temozolomide Recurrence |
Brain Neoplasms Brain Stem Glioma, Childhood O(6)-benzylguanine Glioma Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |
Disease Attributes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Brain Stem Neoplasms Central Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms Brain Diseases Temozolomide Pharmacologic Actions |
Recurrence Brain Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Therapeutic Uses Infratentorial Neoplasms O(6)-benzylguanine Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |