Clinical trial · Interventional
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab
NCT01743950CI-TRIAL-00106402terminatedPhase 2Results postedClinicalTrials.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): slow accrual
Summary
Brief summary (as posted)
To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| PRDR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab-naïve with recurrent IDH wildtype high grade glioma
- description
- 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
- interventionNames
- Drug: Bevacizumab
- Radiation: PRDR
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma
- description
- 27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression
- interventionNames
- Drug: Bevacizumab
- Radiation: PRDR
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines * Recurrent disease based on combination of clinical, imaging or histologic confirmation * Must have previously received radiation and temozolomide to treat their glioma * Bevacizumab naive patients must be \> 5 months post completion of initial radiation therapy * Bevacizumab exposed patients must be \> 3 months post completion of initial radiation therapy * Age must be \>18years, KPS must be greater than 60 * Hematology, chemistry and a urinalysis must meet protocol specified criteria Exclusion Criteria: * Pregnant or breastfeeding * Uncontrolled hypertension (\>160/90mmHg) * Prior malignancy unless treated \>1 year prior to study and have been without treatment and disease free for 1 yr * active second malignancy unless non-melanoma skin cancer or cervical cancer in situ
References
Publications (0)
Data not yet available
No reference posted for this study.