Clinical trial · Interventional
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas
Avastin in Combination With Temozolomide for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas
NCT00612339CI-TRIAL-00010413completedPhase 2Results postedClinicalTrials.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)
Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate. Secondary objective- To determine safety of Avastin \& Temozolomide in unresectable glioblastoma patients
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin and Temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin and Temozolomide
- description
- Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
- interventionNames
- Drug: Avastin and Temozolomide
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 4 months
- description
- The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients have histologically confirmed diagnosis of WHO gr IV primary malignant glioma. Patients will be unresectable or have multifocal disease. * Age ≥ 18years \& life expectancy of \>12 weeks * Evidence of measurable primary CNS neoplasm on contrast enhanced MRI. * Interval of \<1 week between prior biopsy/4 weeks from surgical resection \& enrollment on protocol * Karnofsky ≥60% * Hemoglobin ≥9g/dl, ANC ≥1,500 cells/microliter, platelets ≥125,000 cells/microliter * Serum creatinine ≤1.5 mg/dl, serum SGOT \& bilirubin ≤1.5 x ULN * For patients on corticosteroids, they must have been on stable dose for 1 week prior to entry, if clinically possible, \& dose should not be escalated over entry dose level * Signed informed consent approved by IRB prior to patient entry * No evidence of \> grade 1 CNS hemorrhage on baseline MRI/CT scan * If sexually active, patients will take contraceptive measures for duration of treatments Exclusion Criteria: * Pregnancy/breast feeding * Co-medication that may interfere with study results * Active infection requiring IV antibiotics * Prior or current Treatment w XRT/chemo for brain tumor, irrespective of grade of tumor * Evidence of \> grade 1 CNS hemorrhage on baseline MRI or CT scan Avastin-Specific Concerns: * Inadequately controlled hypertension * Any prior history of hypertensive crisis/hypertensive encephalopathy * New York Heart Association Grade II or \> congestive heart failure * History of myocardial infarction/unstable angina \< 6 months prior to study enrollment * History of stroke/transient ischemic attack \< 6 months prior to study enrollment * Significant vascular disease * Symptomatic peripheral vascular disease * Evidence of bleeding diathesis/coagulopathy * Major surgical procedure, open biopsy,/significant traumatic injury within 28 days prior to study enrollment/anticipation of need for major surgical procedure during course of study * Core biopsy/other minor surgical procedure, excluding placement of vascular access device, \<7 days prior to study enrollment * History of abdominal fistula, GI perforation, /intra-abdominal abscess \<6 months prior to study enrollment * Serious, non-healing wound, ulcer, or bone fracture * Proteinuria at screening as demonstrated by either * UPC ratio ≥1.0 at screening OR * Urine dipstick for proteinuria ≥2+ * Known hypersensitivity to any component of Avastin * Pregnant/lactating. Use of effective means of contraception in subjects of child-bearing potential * Current, ongoing treatment with full-dose warfarin or its equivalent
References
Publications (0)
Data not yet available
No reference posted for this study.