Clinical trial · Interventional
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan
Phase II Study of Bevacizumab Plus Either Temozolomide or Etoposide for (GBM) Patients Who Have Failed Bevacizumab Plus Irinotecan
- 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)
Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety \& tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival \& overall survival of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temo + Avastin | Drug | — | UNRESOLVED |
| VP-16 + Avastin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temo + Avastin
- description
- Patients treated with bevacizumab + temozolomide
- interventionNames
- Drug: Temo + Avastin
- type
- EXPERIMENTAL
- label
- VP-16 + Avastin
- description
- Patients treated with bevacizumab and VP-16 (etoposide)
- interventionNames
- Drug: VP-16 + Avastin
Primary outcomes (1)
- measure
- The Primary Outcome Measure is 6 Month Progression-free Survival.
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts have confirmed diagnosis of GBM \& radiographic evidence of recurrence following prior therapy w bev + irinotecan * Age \>18 yrs * Interval of \>4 wks between prior surgical resection/1 week from stereotactic biopsy * Interval of \>12 wks from end of prior external beam radiation therapy (XRT) unless there is new area of enhancement consistent w recurrent tumor outside of XRT field,/there are progressive changes on MRI on \>2 consecutive MRI scans \>4wks apart, /there is biopsy-proven tumor progression * Interval of \>4 wks from prior chemo / investigational agent unless pt has recovered from all anticipated toxicities associated w that therapy. * Eastern Cooperative Oncology Group (ECOG) 0-1 * Hematocrit \>29percent, absolute neutrophil count (ANC)\>1,000 cells/ml l, platelets \> 100,000 cells/ml l * Serum creatinine\<1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) \& bilirubin\<1.5 times upper limit of normal (ULN) * Signed informed consent approved by Institutional Review Board (IRB) prior to pt entry * No evidence of hemorrhage on baseline MRI/CT scan other than those that are stable gr1 * If sexually active, pts will take contraceptive measures for duration of treatments Exclusion Criteria: * Co-medication that may interfere w study results * Active infection requiring intravenous antibiotics * Progression to daily etoposide/progression to daily temo * Gr3/greater toxicity related to prior bev therapy,/prior temozolomide/etoposide * Requires therapeutic anti-coagulation with warfarin. * Inability to comply w study and/or follow-up procedures * Current, recent,/planned participation in experimental drug study other than Genentech-sponsored bev cancer study * Inadequately controlled hypertension * Any prior history of hypertensive crisis/hypertensive encephalopathy * New York Heart Association (NYHA) Gr II/greater congestive heart failure * History of myocardial infarction (MI)/unstable angina within 6 mths prior to study enrollment * History of stroke/transient ischemic attack within 6 mths prior to study enrollment * Significant vascular disease * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment * Serious, non-healing wound, ulcer, or bone fracture * Proteinuria at screening as demonstrated by either: * urine protein:creatinine (UPC) ratio \>1.0 at screening / * Urine dipstick for proteinuria ≥ 2+ * Known hypersensitivity to any component of bevacizumab * Pregnant or lactating. Use of effective means of contraception in subjects of child-bearing potential
References
Publications (0)
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