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A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma

NCT02157103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-05-17

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Bevacizumab 25 mg in 1 ml subcutaneously daily

Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • William L. Read, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-11-30
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157103 on ClinicalTrials.gov