TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT02663271
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab will be given at 10mg/kg IV every 2 weeks.
  • Optune — DEVICE
    Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
  • Brain MRI — OTHER
    Brain MRI will be done at screening and every 8 weeks.
  • Quality of Life Questionnaires — OTHER
    The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.

Study Details

Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when properly tuned, very low intensity, intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM Therapy) is a portable battery operated device, which produces TTFields within the human body by means of surface transducer arrays. The TTFields are applied to the patient by means of surface transducer arrays that are electrically insulated, so that resistively coupled electric currents are not delivered to the patient. Optune is currently FDA-approved as a single modality treatment for recurrent GBM when both surgical and radiotherapy options have been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM. This research study is being performed to determine whether or not TTFields combined with pulsed bevacizumab treatment increases overall survival in patients with bevacizumab-refractory GBM compared to historical controls treated with continuous bevacizumab alone or in combination with other chemotherapy.

Key Dates

First listed
Jan 26, 2016
Start date
Dec 19, 2016
Status verified
May 2022
Primary completion
Jun 11, 2021
Completion
Jun 11, 2021

Study Design

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

Arms

  • Experimental: Optune+Pulsed Bevacizumab
    The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.

Primary Outcome Measure

Overall Survival [ Time Frame: from date of starting Optune to date of death or censoring, whichever comes first, assessed up to 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-
Washington UniversitySt LouisMissouri63110-

Find similar trials in Gainesville, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Florida· Gainesville, FLWashington University· St Louis, MO

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