A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT02157103
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

STUDY BACKGROUND: This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA approved for the treatment of glioblastoma that gets worse after standard therapy. For glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see if bevacizumab works as well when it is given as a daily subcutaneous shot as it does when given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The dose of bevacizumab given on this study is in total slightly lower than the FDA approved dose for glioblastoma. STUDY DESCRIPTION: About 10 people will take part in the study. Participants or caregivers will be educated on injection and given prefilled syringes to take home. Participants or caregivers will administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the refrigerator. Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks, the follow up interval can be increased to every 6 weeks at the treating physician's discretion. Participants can keep taking the bevacizumab until: * Tests show that they are not benefiting from it, * The participant has a bad side effect related to study treatment, * The participant can no longer comply with study requirements, or * The participant or doctor feels it is no longer in the participant's best interest.

Key Dates

First listed
Jun 5, 2014
Start date
Jan 31, 2014
Status verified
Apr 2018
Primary completion
Nov 30, 2016
Completion
Jan 31, 2018

Study Design

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

Arms

  • Experimental: Bevacizumab
    Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.

Primary Outcome Measure

Number of Participants With Change in Peritumoral Enhancement/Edema [ Time Frame: 1 cycle (3 weeks) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Winship Cancer InstitututeAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Emory University Hospital Midtown· Atlanta, GAEmory University Winship Cancer Institutute· Atlanta, GA

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