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Monoclonal Antibodies

bevacizumab for Glioblastoma

Phase 2
Waitlist Available
Led By Christina Tsien
Research Sponsored by Radiation Therapy Oncology Group
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 from randomization to last follow-up. maximum follow-up at time of analysis was 52.8 months.
Awards & highlights

Study Summary

This trial is testing how well bevacizumab works in treating patients with recurrent glioblastoma, either with or without radiation therapy.

Eligible Conditions
  • Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 52.8 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 52.8 months. 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
Number of Participants With Grade 3+ CNS Toxicity More Than 90 Days of Start of Radiation Therapy Reported as Possibly/Probably/Definitely Related to Protocol Treatment
Percentage of Participants Progression-free at 6 Months
Percentage of Participants With Complete or Partial Best Response
+2 more

Side effects data

From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031
100%
Headache
100%
Fatigue
83%
Lymphocyte count decreased
83%
Hemoglobin Increase
83%
Nausea
83%
Platelet count decreased
67%
Memory impairment
67%
Bicarbonate Serum-low
67%
Constipation
67%
Dizziness
67%
Gait disturbance
67%
Pyramidal Tract Dysfunction
50%
Hypoalbuminemia
50%
Hyponatremia
50%
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)
50%
METABOLIC/LABORATORY (elevated LDH)
50%
Edema limbs
50%
Leukocytosis
50%
METABOLIC/LABORATORY (Elevated BUN)
50%
Mood Alteration
50%
Speech Impairment
33%
Neuropathy, Sensory Legs/Toes tingling
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Aspartate aminotransferase (AST) increased
33%
Taste Alteration
33%
Stomach pain
33%
Diplopia
33%
Muscle weakness- Whole body/generalized
33%
OCULAR/VISUAL (Right & Left visual field deficits)
33%
Hypokalemia
33%
Hypophosphatemia
33%
Alanine aminotransferase (ALT) increased
33%
Alkaline phosphatase increased
33%
Anorexia
33%
Bruising
33%
Confusion
33%
Diarrhea
33%
Gait/walking (wide based ataxic hemiparetic)
33%
Hyperglycemia
33%
Hypoglycemia
33%
METABOLIC/LABORATORY (low creatinine)
33%
METABOLIC/LABORATORY (low protein)
33%
Muscle weakness lower extremity
33%
Seizure
33%
Somnolence
17%
Dehydration
17%
DECUBITUS Ulcer Sacrum
17%
Hyperuricemia
17%
Allergic rhinitis
17%
Bloating
17%
Irregular Menses
17%
Pain (Neuropathic in perineal/buttock)
17%
Heartburn
17%
Hypocalcemia
17%
Mental Status Altered
17%
Infection with Normal ANC (Neck NOS), cellulitis
17%
METABOLIC/LABORATORY (low chloride)
17%
Mucositis oral
17%
Obstruction GI (STOMACH-small bowel nos)
17%
Epistaxis
17%
Tremor
17%
Blood bilirubin increased
17%
Blurred vision
17%
Cholesterol high
17%
Creatinine increased
17%
Cushingoid
17%
Bump at sutura site
17%
Multiple scabs
17%
Dysphagia
17%
Edema cerebral
17%
Gait/walking Impaired mobility
17%
Gastrointestinal (sensitivity to smell)
17%
Hiccups
17%
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum
17%
Joint Pain
17%
METABOLIC/LABORATORY (high chloride)
17%
METABOLIC/LABORATORY (low uric acid)
17%
OCULAR SURFACE DISEASE
17%
OCULAR/VISUAL (Right homonymous hemianopsia)
17%
PAIN (BACK)
17%
Pain in extremity
17%
Pruritus
17%
Sinus bradycardia
17%
Voice alteration
17%
Weight loss
17%
Sensory loss left side
17%
Dyspnea
17%
Vomiting
17%
Hypertriglycedidemia
17%
Infection with Normal ANC (Neck NOS), herpes zoster
17%
Insomnia
17%
Neuropathy, Numbness, Right sided
17%
Sore throat
17%
Urinary tract infection
17%
Hyperpigmentation (hands & knuckles)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Vorinostat + Bevacizumab
Phase II: Bevacizumab
Phase II: Bevacizumab + Vorinostat 400 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bevacizumab + RTExperimental Treatment2 Interventions
Radiation therapy with bevacizumab every 2 weeks
Group II: BevacizumabActive Control1 Intervention
Bevacizumab every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,984 Total Patients Enrolled
322 Trials studying Glioblastoma
22,933 Patients Enrolled for Glioblastoma
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,745 Total Patients Enrolled
19 Trials studying Glioblastoma
6,808 Patients Enrolled for Glioblastoma
Christina TsienPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA certified bevacizumab for therapeutic use?

"There is existing evidence that bevacizumab has safety considerations, so it received a rating of 2."

Answered by AI

What is the current cohort size of this research endeavor?

"Unfortuntely, this clinical trial is no longer open for enrollment. The first posting was on December 20th 2012 and the last update was made on September 29th 2020. For those looking to participate in a similar study, there are currently 1393 studies admitting participants with glioblastoma as well as 355 trials utilizing bevacizumab actively recruiting."

Answered by AI

Are there any hospitals that are actively conducting this trial at the present time?

"This experiment is currently running at Lowell General Hospital in Massachusetts, Door County Cancer Center in Wisconsin, and the University of Alabama at Birmingham in Alabama. Additionally, there are 31 other sites participating across the United States."

Answered by AI

Is this experiment currently available to participants?

"Clinicaltrials.gov indicates that this clinical trial has concluded its participant search, with the original post date being December 20th 2012 and the last update coming on September 29th 2020. Yet 1748 other medical studies are still presently accepting patients into their trials."

Answered by AI

What are the common indications for utilizing bevacizumab?

"Bevacizumab is often prescribed to treat cancerous growths. Additionally, it has been found useful for conditions such as recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection and locally advanced nonsquamous non-small cell lung carcinoma."

Answered by AI

Are there any other studies which have evaluated the efficacy of bevacizumab?

"At this time, 355 research initiatives are utilizing bevacizumab with 89 of them in the advanced Phase 3 stage. Most tests administered on this drug have taken place in Taibei, Taiwan; however, there are 17017 other clinical trial locations worldwide running studies with bevacizumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
2012. "Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01730950.
~15 spots leftby Apr 2025
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