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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.

This is Phase II study with the combination of Avastin \& Temozolomide for unresectable or multifocal WHO grade IV malignant glioma patients. Patients will receive up to 4 cycles of Avastin \& Temozolomide . Avastin administered at 10 mg/kg every 14 days beginning minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide will be dosed at 200 mg/m2 daily x 5 days in 28-day cycle. Patients will have baseline MRI \& repeat MRI every 4 weeks. If there is no evidence of disease progression after each cycle, or unacceptable toxicity, or as determined by investigators, patient non-compliance or patient withdraws consent to continue therapy \& requests discontinuation, patients will receive up to 4 cycles of Avastin \& Temozolomide, then proceed with standard XRT therapy, \& future therapy after 4 cycles will be at discretion of patient \& treating physicians.

Avastin and Temozolomide

Katherine B Peters, MD, PhD

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

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.

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

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.

Genentech, Inc.

Schering-Plough

Duke University

CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas	NCT00612339	Glioblastoma Gliosarcoma	Avastin and Tem...	18 Years -	Duke University
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas	NCT00612339	Glioblastoma Gliosarcoma	Avastin and Tem...	18 Years -	Duke University
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas	NCT00612339	Glioblastoma Gliosarcoma	Avastin and Tem...	18 Years -	Duke University

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