Clinical trial · Interventional
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
NCT01526837CI-TRIAL-00028598terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigators decision
Summary
Brief summary (as posted)
This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bevacizumab (Avastin)
- description
- Open-label, dose-escalating study conducted in cohorts of 1-3 patients treated at increasing doses of bevacizumab in the dose range of 1-25mg/Ml. A maximum of 24 subjects will be treated in this study (up to 8 cohorts of 3 subjects).
- interventionNames
- Drug: Avastin
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
- timeFrame
- 4 weeks
Secondary outcomes (2)
- measure
- Number of Adverse Events
- timeFrame
- 12 months
- description
- All adverse events will be recorded in the case report form.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Recurrent Glioblastoma 2. At least 12 weeks expected survival (KPS \>60) 3. 18 years of age or older 4. Able and willing to participate Exclusion Criteria: 1. Any prior diagnosis of any other cancer or other concurrent malignancy. 2. Planned use or current use of other investigation therapy. 3. Systemic autoimmune disease 4. HIV positive 5. Concurrent life threatening disease 6. Impaired organ function 7. Active infection 8. Inadequately controlled hypertension 9. Congestive heart failure 10. Myocardial infection/unstable angina within 6 months 11. Stroke within 6 months 12. Pheripheral vascular disease 13. History of abdominal fistula/gastrointestinal performation 14. Non-healing wound 15. Coagulation disease 16. Known allergy to study treatments 17. Pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.