Avastin in Combination With Temozolomide for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas
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 & Temozolomide. Avastin administered at 10 mg/kg every 14 days beginning a
minimum of 7 days after biopsy/28 days after craniotomy. Temozolomide dosed at 200 mg/m2
daily for 5 days in 28-day cycle. Patients will receive up to 4 cycles of Avastin &
Temozolomide, then proceed with standard XRT. Study will use 2-stage "minimax" study design
in which 21 subjects are accrued during 1st stage, with possibility that additional 20
patients accrued during 2nd stage. In initial Phase I & II trials, 4 potential
Avastin-associated safety signals were identified: hypertension, proteinuria, thromboembolic
events, & hemorrhage. Avastin-associated adverse events in Phase III trials include
congestive heart failure, GI perforations, wound healing complications, & arterial
thromboembolic events. Most common toxicity associated with Temozolomide has been mild
myelosuppression.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
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.
4 months
No
Katherine B Peters, MD, PhD
Principal Investigator
Duke University Health System
United States: Institutional Review Board
Pro00001022
NCT00612339
August 2007
May 2012
Name | Location |
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Duke University Health System | Durham, North Carolina 27705 |