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Monoclonal Antibodies

Bavituximab for Glioblastoma

Phase 2
Waitlist Available
Led By Elizabeth R Gerstner, MD
Research Sponsored by Massachusetts General Hospital
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 every 3 months for 5 years
Awards & highlights

Study Summary

This trial is testing whether adding Bavituximab to the standard treatment of Temozolomide and radiation therapy can help to control Glioblastoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Progression Free Survival
Radiographic Response

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641
34%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Constipation
26%
Diarrhoea
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Chills
11%
Gastric cancer
11%
Hypothyroidism
11%
Headache
11%
Hypertension
11%
Myalgia
11%
Arthralgia
10%
Asthenia
10%
Hypoalbuminaemia
10%
Abdominal distention
10%
Back pain
8%
Depression
8%
Insomnia
8%
Ascites
8%
Dysphagia
8%
Urinary tract infection
8%
Muscular weakness
8%
Rash
7%
Dyspepsia
7%
Fall
7%
Hyponatraemia
7%
Pleural effusion
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
5%
Dysuria
5%
Hyperkalaemia
5%
Hypotension
5%
Dry skin
5%
Infusion related reaction
5%
Abdominal discomfort
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
3%
Death
3%
Hypokalaemia
3%
Generalized oedema
3%
Cough
3%
Vision blurred
3%
Peripheral sensory neuropathy
3%
Blood bilirubin increased
3%
Hypophosphataemia
2%
Multiple organ dysfunction syndrome
2%
Atrioventricular block
2%
Biliary tract infection
2%
Cancer pain
2%
Metastatic gastric cancer
2%
Disease progression
2%
Acute myocardial infarction
2%
Corona virus infection
2%
Oesophageal cancer metastatic
2%
Encephalopathy
2%
Acute respiratory failure
2%
Facial paralysis
2%
Loss of consciousness
2%
Transient ischaemic attack
2%
Acute kidney injury
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Pneumonia aspiration
2%
Pneumonitis
2%
Hypoxia
2%
Respiratory failure
2%
Upper respiratory tract infection
2%
Pelvic pain
2%
Neutrophil count decreased
2%
Blood cholesterol increased
2%
Large intestinal obstruction
2%
Obstruction gastric
2%
Cardiac arrest
2%
Malignant ascites
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bavituximab + Standard of Care Radiation + TemozolomideExperimental Treatment3 Interventions
Bavituximab will be administered weekly intravenously Temozolomide will be administered daily Standard of Care Radiation will be administered per hospital guideline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bavituximab
2011
Completed Phase 2
~300
Radiation
2003
Completed Phase 3
~1020
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,599 Total Patients Enrolled
2 Trials studying Glioblastoma
55 Patients Enrolled for Glioblastoma
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,319 Total Patients Enrolled
26 Trials studying Glioblastoma
3,718 Patients Enrolled for Glioblastoma
Peregrine PharmaceuticalsIndustry Sponsor
21 Previous Clinical Trials
1,328 Total Patients Enrolled
3 Trials studying Glioblastoma
113 Patients Enrolled for Glioblastoma

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
Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma
Elizabeth R. Gerstner, MD 2017. "Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03139916.
~5 spots leftby Apr 2025
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