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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: | NCT00045721 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy placed into the surrounding tissue after surgery to remove the tumor may kill any remaining tumor cells. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining O(6)-benzylguanine with carmustine implants in treating children who have recurrent malignant glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: O6-benzylguanine Drug: polifeprosan 20 with carmustine implant Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of GLIADEL and O(6)-Benzylguanine in Pediatric Patients With Recurrent Malignant Gliomas |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of O(6)-benzylguanine.
Patients receive O(6)-benzylguanine (O6-BG) IV over 1 hour immediately followed by O6-BG IV continuously for 9 days. Two days after initiation of continuous infusion of O6-BG, patients undergo maximal tumor debulking. At the time of surgery, patients receive up to 8 polifeprosan 20 wafers with carmustine (Gliadel) implanted into the resection cavity.
Cohorts of up to 14 patients receive escalating doses of continuous infusion O6-BG until the optimally biologically effective dose (BED) is determined.
The BED is defined as the dose at which at least 11 of 14 patients meet the target of complete suppression of alkylguanine-DNA alkyltransferase levels.
Patients are followed at day 11, at weeks 2, 4, 6, 8, and 12, at months 6, 9, and 12, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0372 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
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: | Ian F. Pollack, MD | Children's Hospital of Pittsburgh |
Study ID Numbers: | CDR0000257268, PBTC-009 |
Study First Received: | September 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00045721 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood cerebral astrocytoma |
Astrocytoma Carmustine Adjuvants, Immunologic Central Nervous System Neoplasms Recurrence Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma O(6)-benzylguanine Glioma Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Carmustine Enzyme Inhibitors Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal O(6)-benzylguanine Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |