Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Ajay Niranjan
Study ID
NCT02120287
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma - Category
  • Glioblastoma Multiforme

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.
  • Magnetic Resonance Spectroscopy (MRS) — PROCEDURE
    Subjects will have MRS prior to BZ-SRS.
  • Border Zone Stereotactic Radiosurgery (BZ-SRS) — PROCEDURE
    The 'border zone' of the tumor will be targeted by SRS in a single session.

Study Details

This is a phase II study on the usage of stereotactic Gamma Knife radiosurgery as a boost to the tumor bed border zone in conjunction with the usage of bevacizumab.

Key Dates

First listed
Apr 22, 2014
Start date
May 31, 2014
Status verified
Apr 2019
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018

Study Design

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

Arms

  • Experimental: BZ-SRS with Bevacizumab
    All patients will receive Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213-

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By research site
University of Pittsburgh· Pittsburgh, PA

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