Status:
COMPLETED
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Schering-Plough
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Subjects have histologically confirmed WHO gr IV primary malignant glioma that is unresectable/multifocal. This is Phase II study where up to 41 subjects will receive up to 4 cycles of Avastin \& Temo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00612339
Start Date
August 1 2007
End Date
May 1 2012
Last Update
May 27 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710