Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme

NCT00883298 | Completed Phase 2 DMC

• 1 other identifier: AVF4514s
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab. Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.

Conditions

Recurrent Glioblastoma Multiforme; Recurrent Gliosarcoma

Keywords

temozolomide; bevacizumab; Temodar; Avastin; glioblastoma multiforme; gliosarcoma; glioma; GBM; brain tumor

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival.

  6 months

Secondary Outcomes (3)

• Radiographic response (Gd-MRI) including specialized MRI sequences (T2/FLAIR).

  every eight weeks

• Incidence and severity of toxicity.

  6 months

• Tumor DNA (MGMT) analysis as it relates to survival.

  6 months

Study Arms (1)

Open Label

EXPERIMENTAL

temozolomide plus bevacizumab administered as open label single arm treatment

Drug: temozolomide and bevacizumab

Interventions

temozolomide and bevacizumab DRUG

oral temozolomide 100 mg/m2 days 1-5 \& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \& 5 every 28-day cycle

Also known as: Temodar, Avastin

Open Label

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed diagnosis of a glioblastoma multiforme/gliosarcoma and:
• Must have completed at least 2 cycles of adjuvant chemotherapy
• Age \> 18 years
• Karnofsky \> 60%
• Hematocrit \> 29%, ANC \> 1,500 cells/dl, platelets \> 125,000 cells/dl
• Serum creatinine \< 1.5 mg/dl, BUN \< 25 mg/dl, serum SGOT and bilirubin \< 1.5 times upper limit of normal
• If on corticosteroids, must be on a stable dose for 1 week prior to entry; if clinically possible, the dose should not be escalated over entry dose level
• Signed informed consent approved by the Institutional Review Board prior to study entry
• If sexually active, will take contraceptive measures for the duration of the treatments

You may not qualify if:

• Prior toxicity grade ≥ 3 with TMZ
• Prior treatment with bevacizumab
• Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
• Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
• Confirmed diagnosis of HIV infection
• Have received investigational drugs less than 4 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy
• Have received chemotherapy within 2 weeks prior (6 weeks for nitrosourea) to entry on this study, or who have not recovered from the toxic effects of such therapy
• Have received biologic, immunotherapeutic or cytostatic agents within 1 week prior to entry on this study or who have not recovered from the toxic effects of such therapy
• Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant
• Have received radiation therapy within 2 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
• Surgical resection of brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
• Have had any surgery other than resection of a brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
• Unwilling to or unable to comply with the protocol
• Evidence of tumor progression within on immediate post radiation brain imaging

Sponsors & Collaborators

• Center for Neurosciences, Tucson: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Glioma; Brain Neoplasms

Interventions

Temozolomide; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael A. Badurddoja, MD

  Center for Neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, NeuroOncologist

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)