What side effects are associated with this type of intervention?

Common treatments for Low Grade Glioma, such as Bevacizumab and Vinblastine, have several known side effects. Bevacizumab can cause hypertension, proteinuria, bleeding, thromboembolic events, and gastrointestinal perforations. Vinblastine may lead to myelosuppression (neutropenia, anemia, thrombocytopenia), gastrointestinal symptoms (nausea, vomiting), and peripheral neuropathy. Combining these treatments may heighten the risk of these adverse effects.

What prior FDA approvals exist?

Bevacizumab, an anti-VEGF monoclonal antibody, has been studied for its efficacy in treating various types of gliomas, including Low Grade Glioma (LGG). While specific FDA approvals for Bevacizumab in LGG are not detailed, it is approved for recurrent glioblastoma, a more aggressive form of brain tumor. Other treatments for gliomas that target angiogenesis include drugs like Pazopanib and Sorafenib, which are tyrosine kinase inhibitors affecting VEGF receptors. These treatments aim to inhibit tumor growth by preventing the formation of new blood vessels.

What other types of research exist?

Promising novel alternatives to Bevacizumab for Low Grade Glioma patients include: 1) Nivolumab, an immunotherapy that has shown potential in recurrent glioblastoma and may be explored for LGG. 2) Emerging VEGF antagonists, which are being developed for various cancers and may offer new options for LGG. 3) HIF-2 antagonists, targeting hypoxia-inducible factors involved in tumor growth and angiogenesis. These alternatives should be discussed with a healthcare provider to determine the best course of action based on individual patient needs and the latest clinical trial data.

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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

Must not have

Children under 6 months of age

Use of any investigational agent, systemic, targeted or immunotherapy prior to the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year off therapy

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing if adding Bevacizumab to Vinblastine helps children with worsening brain tumors more than using Vinblastine alone. Vinblastine is given regularly, and Bevacizumab is added periodically for several months. Bevacizumab is an anti-VEGF antibody approved for treating various cancers and has been studied for use in children with brain tumors.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is under 6 months old.

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I have not used any experimental drugs before starting this study treatment.

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I have a serious heart condition.

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I have a bone fracture that hasn't healed properly.

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I am currently taking certain medications.

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I have not had major surgery in the last 28 days.

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I have had a serious blood clot in the past.

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I have an active stomach or duodenal ulcer.

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I currently have an ongoing infection.

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I have a surgical wound that hasn't healed.

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I have a bleeding disorder that increases my risk of bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year off therapy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Low Grade Glioma (LGG) include Bevacizumab, which inhibits VEGF to prevent angiogenesis, crucial for tumor growth. Vinblastine disrupts microtubule formation, inhibiting cell division, while carboplatin causes DNA damage leading to apoptosis. These mechanisms are vital for LGG patients as they target the tumor's growth and spread, potentially improving survival and quality of life.

Phase I/II study of bevacizumab with BKM120, an oral PI3K inhibitor, in patients with refractory solid tumors (phase I) and relapsed/refractory glioblastoma (phase II).Treatment response of bevacizumab combination chemotherapy in recurrent glioblastoma: A long-term retrospective study in Taiwan.