A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

Completed · Early Phase 1

Conditions studied: Newly Diagnosed High-Grade Gliomas, Diffuse Intrinsic Pontine Glioma

In brief

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.

Key facts

Study ID

NCT00890786

Run by

Children's Hospital Medical Center, Cincinnati

People needed

27

Starts

2009-05-01

Expected to finish

2017-12-01

Last updated by the study team

2018-05-02

Who can join

Age: 3 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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