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Monoclonal Antibodies

Neuradiab in combination with Avastin for Brain Tumor

Phase 2
Waitlist Available
Led By David A. Reardon, MD
Research Sponsored by Bradmer Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days after Neuradiab administration in patients with a first or second recurrence of glioblastoma multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant glioma.

Eligible Conditions
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The safety of Neuradiab® when followed by Avastin therapy will be assessed based on Investigator reported symptomatic toxicity findings on physical exam, and Adverse Events.
Secondary outcome measures
Overall survival (OS). Data will be reported based on a dataset of 60 patients.
Time to progression (TTP). Data will be reported based on a dataset of 60 patients.

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neuradiab in combination with AvastinExperimental Treatment1 Intervention
Patients will be treated following surgical removal of recurrent glioblastoma with a single intracavitary dose of Neuradiab® delivering 44 Gy±10% to the ridge of the surgically created resection cavity followed by therapy with Bevacizumab (Avastin) at a minimum of 30 days after Neuradiab administration. Treatment with Bevacizumab will consist of 10mg/kg iv on days 1 and 15 every 28 days. Other chemotherapies (in addition to Avastin) will be permitted based on most current clinical practice and clinical evaluation of the patient.

Find a Location

Who is running the clinical trial?

Bradmer Pharmaceuticals Inc.Lead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
David A. Reardon, MDPrincipal InvestigatorThe Preston Robert Tisch Brain Tumor Center
14 Previous Clinical Trials
757 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme
2009. "Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00906516.
~4 spots leftby Apr 2025
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