Clinical trial · Interventional
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery. The study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCNU Wafer | Drug | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCNU wafter followed by chemotherapy
- description
- Surgical Implantable BCNU wafer followed by Chemotherapy with Irinotecan and Bevacizumab for up to one year
- interventionNames
- Drug: BCNU Wafer
- Drug: Irinotecan
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- To assess disease free survival
- timeFrame
- 6 and 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted. * Must have had prior treatment with standard doses of Temodar * KPS \>50; ECOG \<3 * Predicted life expectancy of \> 3 months * Study entry must be within 5 weeks of surgical resection Exclusion Criteria: * Prior exposure to VEGF inhibitors or Irinotecan * Intracranial bleed as defined by CT or MRI less than 6 months prior to entry * GI bleed less than 6 months prior to entry * Uncontrolled concurrent illness that would limit compliance with study requirements
References
Publications (0)
Data not yet available