Clinical trial · Interventional
A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
A Pilot Study of Bevacizumab-Based Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
NCT00890786CI-TRIAL-00032744completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
| Newly Diagnosed High-Grade Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HGG
- description
- Temozolomide, Bevacizumab, and Irinotecan according to the treatment schedule in the intervention section.
- interventionNames
- Drug: Temozolomide
- Drug: Bevacizumab
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- DIPG
- description
- Temozolomide, Bevacizumab, and Irinotecan according to the treatment schedule in the interventions section.
- interventionNames
- Drug: Temozolomide
- Drug: Bevacizumab
- Drug: Irinotecan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.