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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Camptothecin; Dacarbazine; Irinotecan; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.