Bevacizumab for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lenox Hill Brain Tumor Center, New York, NY
Glioblastoma+2 More
Bevacizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether repeated intra-arterial Bevacizumab therapy is safe and effective in the treatment of newly diagnosed malignant glioma.

See full description

Eligible Conditions

  • Glioblastoma
  • Glioblastoma Multiforme (GBM)
  • Neoplasms, Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Bevacizumab will improve 2 primary outcomes and 1 secondary outcome in patients with Glioblastoma. Measurement will happen over the course of 1 month ongoing.

1 month ongoing
Toxicities
6 month
Composite overall response rate (CORR)
6-month
Progression-free survival (PFS) and Overall survival (OS)

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Bevacizumab
vitreous hemorrhage
22%
worsening of cataract
17%
vitreous syneresis
9%
posterior capsule opacification
9%
colon cancer
4%
pneumonia
4%
pyelonephritis
4%
cranial nerve VI palsy
4%
bradycardia
4%
epiretinal membrane
0%
increased intraocular pressure
0%
congestive heart failure
0%
choroidal detachment
0%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, colon cancer with 4%.

Trial Design

1 Treatment Group

SIACI of Bevacizumab
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. Bevacizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

SIACI of Bevacizumab
Drug
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-month for reporting.

Who is running the study

Principal Investigator
J. B. Z. S. @.
Prof. John Boockvar Zucker SOM @Hofstra/Northwell, MD
Feinstein Institute for Medical Research

Closest Location

Lenox Hill Brain Tumor Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female patients of ≥18 years of age.
Patients with documented histologic diagnosis of glioblastoma multiforme (newly diagnosed)
Patients must have at least one confirmed and evaluable tumor site.∗
*A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
Previous treatment with Bevacizumab.
Women who are pregnant or lactating.
Women of childbearing potential and fertile men who decline to use effective contraception during and for a period of three months after the treatment period.
Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring

Patient Q&A Section

How many people get glioblastoma a year in the United States?

"1,600 babies in the United States develop glioblastoma each year. The 2-year survival of 12% is below the survival rate of 20%-40% in other countries. As glioblastoma tends to develop early, prompt intervention in children at risk is required. Given the shortcomings of the current screening protocol, the incorporation of an adjuvant protocol for all children at risk will be studied, with a view to making the current protocol more inclusive." - Anonymous Online Contributor

Unverified Answer

Can glioblastoma be cured?

"If the glioblastoma was diagnosed as a young child, the survival rate is significantly better (log-rank, p < 0.0001). Younger patients may have a high probability of survival." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"Treatment for glioblastoma is an extremely variable process. Surgical resection is the standard form of treatment for high-grade gliomas with a median survival of 2-3 months from the time of surgery; however, radiotherapy is rarely administered. Atypical presentation and recurrence patterns are reasons why surgical resection is not routinely sought in all patients. Radiotherapy used as adjuvant therapy after surgery is very variable. Temozolomide and temozolomide monotherapy is the standard of care in the treatment of glioblastoma despite its limited impact on survival." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"The authors' research confirmed the presence of four signs in GBM patients, including nausea/vomiting, headache, constipation/stomach ache, and neurological symptoms. The authors hypothesize that tumor-associated neurological symptoms arise from the blood-brain barrier disruption caused by the tumor." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"This rare and rapidly fatal tumour is characterised by an aberrant accumulation of cells that give rise to a heterogeneous cellular 'population', including stem cells and other cell populations involved in tumour development and progression including glioma stem cells and cancer stem cells. Glioblastoma, however, has been found in younger children than in adults with a higher percentage of anaplastic and lower numbers of non-anaplastic malignant glioma. An examination of histological variants of glioblastoma in children and adults is needed to better understand these variants and thereby improve clinical treatments of children with glioblastoma to achieve improved survival rates." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"The study provides evidence of four independent pathways leading to glioblastoma: genetic mutations, altered metabolism, environmental insults and other tumor suppressor events. The current therapeutic paradigm focuses on the cytotoxic function of temozolomide, which was proven to be insufficient when applied as single agent. Recent findings confirms the current hypothesis that resistance to temozolomide develops, most likely through up-regulation of the proteasome system, which reduces the effect of temozolomide. For this effect, additional targeting agents are warranted." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bevacizumab?

"The data indicate that bevacizumab does not increase the rate of grade 3/4 adverse events. Side effects do occur, however, which often resolves at the end of or after cycle 2." - Anonymous Online Contributor

Unverified Answer

How does bevacizumab work?

"As far as we know, there is no existing treatment combination in the treatment setting yet for people with glioblastoma. There are several possible drug combinations that could be explored for this condition in the absence of clinical data: targeting EGFR or PDCD and targeting the PI3K/Akt axis. Since we know of the potential benefit of Bevacizumab in other tumor types, clinicians should consider whether and in what context it could be used as part of their treatment program." - Anonymous Online Contributor

Unverified Answer

How serious can glioblastoma be?

"Most patients with GBM receive adjuvant radiation after treatment with a first-line chemotherapy and chemotherapy boost. These data suggest that GBM is associated with an excellent clinical course and prolonged survival compared with patients who do not receive adjuvant radiation therapy." - Anonymous Online Contributor

Unverified Answer

What is bevacizumab?

"Bevacizumab is effective in achieving an improvement in survival rate in patients with recurrent glioblastoma. However, the benefit is most pronounced in those cases in which the number of surgeries equals one-half or more of the number of treatment cycles. For future treatment of these patients bevacizumab should be used with caution." - Anonymous Online Contributor

Unverified Answer

Has bevacizumab proven to be more effective than a placebo?

"The effect of bevacizumab on progression free survival of recurrent GBM is similar to that seen in the trials conducted in advanced cancers and is likely to result in better quality of life for patients. Further randomized controlled trials of bevacizumab are warranted in this setting." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"The average age was 64.5 years, but a significant proportion of patients were younger and older; therefore, the age distribution should be considered when choosing the optimum treatment strategy for patients with glioblastoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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