Phase 2 N=41 Treatment

Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

Glioblastoma · Gliosarcoma

Bottom Line

View on ClinicalTrials.gov: NCT00612339 ↗

Enrolled (actual)

Serious AEs

24.4%

Results posted

Sep 2012

Primary outcome: Primary: Response Rate — 24.4 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Avastin and Temozolomide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate	24.4	—

Summary

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

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00612339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.