Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-11-30

Brief Summary

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This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

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Detailed Description

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This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.

Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab and Metronomic Temozolomide

Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab administered intravenously 10mg/kg every other week.

Metronomic Temozolomide

Intervention Type DRUG

Temozolomide 50mg/m2 given orally on a daily basis.

Interventions

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Bevacizumab

Bevacizumab administered intravenously 10mg/kg every other week.

Intervention Type DRUG

Metronomic Temozolomide

Temozolomide 50mg/m2 given orally on a daily basis.

Intervention Type DRUG

Other Intervention Names

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Avastin Temodar

Eligibility Criteria

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Inclusion Criteria

* Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma
* Karnofsy Performance Status (KPS) \>/= 60%
* Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.
* An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol
* An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol.
* No evidence of CNS hemorrhage on the baseline MRI or CT scans

Exclusion Criteria

* Life expectancy \< 8 weeks
* Pregnancy or breast feeding
* Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide
* Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No