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| Sponsor: | Pediatric Brain Tumor Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00381797 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of glioma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating young patients with recurrent, progressive, or refractory glioma, medulloblastoma, ependymoma, or low grade glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: irinotecan hydrochloride Procedure: magnetic resonance imaging Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Bevacizumab Plus Irinotecan (Camptosar™) in Children With Recurrent, Progressive, or Refractory Malignant Gliomas, Diffuse/Intrinsic Brain Stem Gliomas, Medulloblastomas, Ependymomas and Low Grade Gliomas |
| Estimated Enrollment: | 140 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | September 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 glioma [closed to accrual as of 4/21/2009] vs intrinsic brain stem tumor [closed to accrual as of 4/21/2009] vs medulloblasomas vs ependymoma vs low grade glioma).
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and irinotecan hydrochloride IV over 90 minutes on day 16 or 17 for course 1. Patients receive bevacizumab and irinotecan hydrochloride on days 1 and 15 for all subsequent courses. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo MRIs of the brain, magnetic resonance perfusion/diffusion, and fludeoxyglucose F 18 positron emission tomography at baseline and periodically during treatment.
After completion of study treatment, patients are followed for 30 days and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 140 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:
Diagnosis of 1 of the following:
Histologically confirmed high-grade glioma (WHO grade III or IV) at any site within the brain, including the following:
Diffuse brain stem glioma
Primary spinal cord malignant glioma with measurable metastatic disease within the brain
Recurrent, progressive, or refractory disease (must have received prior chemoradiotherapy)
Bidimensionally measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 2 planes
PATIENT CHARACTERISTICS:
No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Stewart Goldman, MD 773-880-4562 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Contact: Peter C. Phillips, MD 215-590-2107 | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
| Study Chair: | Sri Gururangan, MD | Duke University |
| Investigator: | Susan Chi, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( James M. Boyett ) |
| Study ID Numbers: | CDR0000499832, PBTC-022 |
| Study First Received: | September 26, 2006 |
| Last Updated: | May 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00381797 History of Changes |
| Health Authority: | Unspecified |
|
childhood high-grade cerebral astrocytoma childhood spinal cord neoplasm childhood oligodendroglioma recurrent childhood medulloblastoma recurrent childhood ependymoma |
|
Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Irinotecan Central Nervous System Neoplasms Bevacizumab Ependymoma Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Glioma |
Nervous System Neoplasms Neoplasms by Histologic Type Growth Substances Nervous System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Camptothecin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Medulloblastoma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |