Bevacizumab and Irinotecan in Treating Young Patients With Recurrent, Progressive, or Refractory Glioma, Medulloblastoma, Ependymoma, or Low Grade Glioma
Completed · Phase 2
Conditions studied: Childhood Cerebral Anaplastic Astrocytoma, Childhood Oligodendroglioma, Childhood Spinal Cord Neoplasm, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma
In brief
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. 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.
Key facts
- Study ID
- NCT00381797
- Run by
- National Cancer Institute (NCI)
- People needed
- 97
- Starts
- 2006-08-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-11-28
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed high-grade glioma (WHO grade III or IV) at any site within the brain, including the following:
- Anaplastic astrocytoma
- Glioblastoma multiforme (including giant cell and gliosarcoma subtypes)
- Anaplastic oligodendroglioma
- Anaplastic ganglioglioma
- Anaplastic oligoastrocytoma
- Diffuse brain stem glioma
- Histologic confirmation not required
- Histologically confirmed medulloblastoma
- Histologically confirmed ependymoma
- Primary spinal cord malignant glioma with measurable metastatic disease within the brain
- Histologic confirmation required
- Neuraxis dissemination allowed provided there is bidimensionally measurable disease within the brain and spinal cord
- Low grade glioma at any site within the brain with or without spinal cord disease
- Recurrent, progressive, or refractory disease (must have received prior chemoradiotherapy)
- No more than 2 prior chemotherapy regimens following relapse
- Bidimensionally measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 2 planes
- If there is spinal cord disease as well, response assessment will be based only upon the measurable tumor in the brain
- No diffuse gliomatosis cerebri with < 1 discrete, measurable lesion
- No evidence of new symptomatic CNS hemorrhage (> grade 2) within the past 2 weeks
- No central non-cerebellar PNET's (e.g., cerebral PNET or pineoblastoma)
- No spinal cord tumors only
- Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
- Absolute neutrophil count ≥ 1,500/mm³ (unsupported)
- Platelet count ≥ 100,000/mm³ (unsupported)
Where it is running
- UCSF Medical Center-Mount Zion — San Francisco, California, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
- Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Texas Children's Hospital — Houston, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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