NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT01894061
Phase
PHASE2
Status
Completed

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
  • NovoTTF-l00A — DEVICE
    NovoTTF-100A will be worn continuously.
  • Quality of Life Assessment — OTHER
    Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire

Study Details

NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.

Key Dates

First listed
Jul 9, 2013
Start date
Sep 18, 2013
Status verified
Feb 2025
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and NovoTTF-100A
    Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.

Primary Outcome Measure

Percent of Participants With 6-month Progression-free Survival (PFS6) [ Time Frame: 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45220-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cincinnati, OH

By research site
University of Cincinnati· Cincinnati, OHCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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