Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioblastoma Multiforme
Intervention: Bevacizumab (Drug); Metronomic Temozolomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Annick Desjardins, MD, Principal Investigator, Affiliation: Duke University Health System
Summary
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.
Clinical Details
Official title: A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 6-Month Progression-free Survival
Secondary outcome: Response RateIncidence and Severity of CNS Hemorrhage and Systemic Hemorrhage Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Duke University Medical Center (Brain Tumor Center), Durham, North Carolina 27710, United States
Additional Information
The Preston Robert Tisch Brain Tumor Center at Duke
Starting date: July 2007
Last updated: May 17, 2013
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