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A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-Month Progression-free Survival

Outcome Description:

Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Annick Desjardins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00000404

NCT ID:

NCT00501891

Start Date:

July 2007

Completion Date:

November 2009

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Brain and Central Nervous System Tumors
  • Recurrent Malignant Glioma
  • Recurrent Glioblastoma Multiforme
  • Avastin
  • Bevacizumab
  • Temodar
  • Temozolomide
  • Glioblastoma
  • Glioma

Name

Location
Duke University Medical Center (Brain Tumor Center) Durham, North Carolina  27710