Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02840409
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2016-01-28
Brief Title:
Vinblastine - Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma LGG
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
A Phase II Open-Labeled Multi-Center Randomized Controlled Trial of Vinblastine - Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma LGG
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label randomized multi-center comparator Phase II trial looking at the addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of initiation of therapy Participants will be randomized to Arm A or Arm B Arm A includes 68 weeks of single agent Vinblastine administered once weekly IV Arm B includes 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 Randomization will take place at the time of registration taking into account NF1 and BRAF-KIAA1549-fusion status
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None