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Vinca alkaloids

Vinblastine + Bevacizumab for Brain Tumor

Phase 2
Waitlist Available
Led By Eric Bouffet, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have satisfactory liver function
Children and adolescents aged 6 months to < 18 years old with Low Grade Glioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year off therapy
Awards & highlights

Study Summary

This trial is testing whether adding the drug Bevacizumab to Vinblastine helps treat children with a type of brain tumor called low grade glioma. The trial will last 68 weeks and compare children who receive just Vinblastine to those who receive both drugs.

Who is the study for?
This trial is for children and teens aged 6 months to less than 18 years with Low Grade Glioma (brain tumor) who haven't had previous treatments except surgery. They must be able to start treatment within two weeks after joining, have stable health conditions, and meet specific blood, liver, kidney function criteria. Sexually active teens must use contraception.Check my eligibility
What is being tested?
The study tests if adding Bevacizumab to Vinblastine improves outcomes in pediatric patients with progressive brain tumors. It's a Phase II trial where participants are randomly assigned to receive either just Vinblastine or both drugs over a period of 68 weeks.See study design
What are the potential side effects?
Possible side effects include bleeding risks, high blood pressure, wound healing complications, and potential allergic reactions related to the drugs being tested. The severity can vary from minor issues like headaches to more serious ones such as internal bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver functions properly.
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I am between 6 months and 18 years old with a Low Grade Glioma.
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My cancer has worsened after surgery.
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My low-grade glioma has been confirmed and tested for BRAF.
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My physical health allows me to perform daily activities.
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I have only had surgery for my tumor, no other treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year off therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year off therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of the addition of Bevacizumab to Vinblastine compared with Vinblastine alone in chemotherapy-naïve pediatric patients with unresectable or progressive Low Grade Gliomas as measured by Response Rate (RR).
Secondary outcome measures
Overall survival (OS) at the end of study.
To determine 6 month, 12 month and 2 year progression free survival (PFS) between vinblastine alone versus in combination with Bevacizumab.
To determine if the prevalence of QOL difficulties in children and adolescents treated for LGG at 1 year off therapy, is significantly higher than the normative population (> 14%).
+3 more
Other outcome measures
To assess the use of novel MR biomarkers to assess disease response in these patients and to correlate these with traditional imaging tools.
To define and describe the toxicities of the agents in combination and of single agent Vinblastine in this treatment naïve population as assessed by CTCAE v 4.03.
Disease
+8 more

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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment2 Interventions
68 weeks of Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered every two weeks IV for the initial 24 weeks.
Group II: Arm AActive Control1 Intervention
68 weeks of single agent Vinblastine administered once weekly IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
FDA approved
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,684 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,428 Previous Clinical Trials
1,088,945 Total Patients Enrolled
Eric Bouffet, MDPrincipal Investigator - The Hospital for Sick Children
The Hospital for Sick Children
4 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

Vinblastine (Vinca alkaloids) Clinical Trial Eligibility Overview. Trial Name: NCT02840409 — Phase 2
Low Grade Glioma Research Study Groups: Arm B, Arm A
Low Grade Glioma Clinical Trial 2023: Vinblastine Highlights & Side Effects. Trial Name: NCT02840409 — Phase 2
Vinblastine (Vinca alkaloids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02840409 — Phase 2

Frequently Asked Questions

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

Can new participants enroll in this clinical trial at this time?

"Yes, as of right now this trial is still looking for participants. August 1st 2016 was when the study was originally posted and the 3/11/2020 date represents the most recent edit."

Answered by AI

For what sorts of medical conditions is Bevacizumab commonly prescribed?

"Bevacizumab is a medication used to treat lymphoma and hodgkins. However, it can also be effective in managing recurrent platinum-resistant epithelial ovarian cancer, malignant neoplasms, and recurrent platinum sensitive primary peritoneal cancer."

Answered by AI

Could you please detail the side effects of Bevacizumab?

"Although there is some clinical evidence to support the safety of Bevacizumab, it did not receive a higher score because Phase 2 trials have yet to demonstrate efficacy."

Answered by AI

What are the most similar past studies to Bevacizumab?

"First explored in 2002 at the Canberra Hospital, bevacizumab has undergone 1071 clinical trials. Right now, there are 408 more active studies underway; a majority of these additional experiments are being conducted in Toronto, Canada."

Answered by AI

Is this clinical trial being conducted at more than one location within the state?

"There are a number of hospitals and medical centres signed up for this clinical trial, 15 in total. These locations include The Hospital for Sick Children in Toronto, CHU du Quebec-Universite Laval in Québec, as well as The Children's Hospital of Philadelphia in Philadelphia."

Answered by AI

What is the total number of participants enrolled in this research project?

"Yes, according to the most recent update on clinicaltrials.gov, this research is still looking for volunteers. The trial was posted on August 1st, 2016 and last updated on March 11th, 2020. They need a total of 150 individuals spread out over 15 different sites."

Answered by AI

Are patients who are over 55 years of age eligible for this clinical trial?

"The aim of this study is to recruit paediatric patients who are between 6 months and 18 years old."

Answered by AI

How do I sign up for the research program?

"This clinical trial is testing a new medication for glioma in patients that are between 6 months and 18 years old. A total of 150 participants are needed for the study."

Answered by AI
~3 spots leftby Jul 2024