NCT01331616

Brief Summary

Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

April 1, 2011

Last Update Submit

November 29, 2021

Conditions

GlioblastomaOptic Neuropathy

Keywords

Prospective studyGlioblastomaAvastinVisual Evoked PotentialOptic neuropathyChemo-radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.

    Does Avastin lead to optic neuropathy in combination w chemo-radiotherapy? Our research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. In our study of VEP, we will be measuring optic nerve function, to asses if there has been any damage.

    1 year

Secondary Outcomes (1)

  • Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment

    1 year

Study Arms (1)

Bevacizumab (Avastin)

EXPERIMENTAL
Drug: Bevacizumab (Avastin)

Interventions

Bevacizumab (Avastin)DRUG

Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.

Bevacizumab (Avastin)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin

You may not qualify if:

  • No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlioblastomaOptic Nerve Diseases

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 8, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 9, 2021

Record last verified: 2021-11