Status:
COMPLETED
A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Newly Diagnosed High-Grade Gliomas
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
3-30 years
Phase:
EARLY_PHASE1
Brief Summary
The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas remains poor despite the use of multi-modal therapy with surgery, radiation therapy and chemotherapy.
Detailed Description
Novel therapies are needed to improve the outcome of these children. Recent studies have demonstrated very promising results of treatment with bevacizumab/irinotecan in patients with recurrent high gr...
Eligibility Criteria
Inclusion
- Patients must be ≥ 3 years of age and ≤ 30 years of age at the time of study entry.
- Diagnosis:
- High-grade glioma;Patients must have had histologically verified anaplastic astrocytoma, glioblastoma multiforme or gliosarcoma.Patients with primary spinal cord tumors are eligible.
- Diffuse intrinsic pontine glioma (DIPG) are eligible.
- Performance Level: Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Prior Therapy: no prior anticancer therapy.
- Concomitant Medications: The use of steroids is permissible.
- Organ Function Requirements All patients must have adequate organ function as defined below.
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Adequate Blood Clotting Defined As: INR, Fibrinogen, and PTT \< Grade 2
- Central nervous system function. Patients with seizures may be enrolled if the seizures are well-controlled with non-enzyme inducing anticonvulsants.
- Informed Consent. Patients and/or parents/legal guardians must have signed an informed consent.
Exclusion
- Patients with metastatic disease (i.e. M+ disease, or disease anywhere other than primary site).
- Patients with evidence of a new intracranial hemorrhage that is larger than a punctate size on baseline MRI scan.
- Allergies: Patients with a history of allergic reaction to Chinese hamster ovary cell products, or other recombinant human antibodies.
- Pregnant or breast feeding women will not be entered on this study.
- Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
- Infection: Patients who require IV antibiotics at time of enrollment, or who are currently receiving treatment for Clostridium difficile infection are excluded.
- Thrombosis: Patients must not have been previously diagnosed with a deep venous or arterial thrombosis (including pulmonary embolism), and must not have a known thrombophilic condition.
- Serious or Non-Healing Wounds
- Surgical Procedures: Patients who have had major surgery should not receive the first dose of bevacizumab until 28 days after major surgery.
- Patients with uncontrolled systemic hypertension.
- Proteinuria with a urine protein (albumin)/creatinine ratio of ≥1.0.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00890786
Start Date
May 1 2009
End Date
December 1 2017
Last Update
May 2 2018
Active Locations (2)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229