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

Completed · Phase 2

Conditions studied: Glioblastoma, Gliosarcoma

In brief

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

Key facts

Study ID

NCT00612339

Run by

Duke University

People needed

41

Starts

2007-08-01

Expected to finish

2012-05-01

Last updated by the study team

2013-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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