Phase 2 Completed N=32 Treatment

Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma

Glioblastoma multiforme

Source: ClinicalTrials.gov NCT00501891 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Apr 2013

Primary outcomePrimary: 6-Month Progression-free Survival — 18.8 percentage of participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 6-Month Progression-free Survival	18.8	—
SECONDARY Response Rate	9	—
SECONDARY Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage	0; 0	—
SECONDARY Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity	0; 14	—

Eligibility 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 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00501891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.