Vinblastine + Bevacizumab for Brain Tumor

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byEric Bouffet, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My liver functions properly.

I am between 6 months and 18 years old with a Low Grade Glioma.

My cancer has worsened after surgery.

+12 more

Exclusion Criteria

Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies

My child is under 6 months old.

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

+14 more

Participant Groups

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.

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

Vinblastine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Velban for: