Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655404
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2020-11-09
Brief Title:
A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
A Pilot and Surgical Study of Larotrectinib for Treatment of Children With Newly-Diagnosed High-Grade Glioma With NTRK Fusion
Status:
RECRUITING
Status Verified Date:
2024-08
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 a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion The evaluation will occur after 2 cycles of the medication Larotrectinib have been given
The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children as well as the safety larotrectinib when given post-focal radiation therapy
The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children as well as the safety larotrectinib when given post-focal radiation therapy
Detailed Description:
In this pilot study we will assess the disease control rate Continued Complete Response-CCR Complete Response-CR Partial Response-PR and Stable Disease-SD as well as survival rate overall survival- OS and progression free survival- PFS in children with newly diagnosed HGG with TRK fusion who receive 2 cycles of larotrectinib monotherapy administered orally twice daily at 100 mgm2 continuously on a 28-day cycle schedule After 2 monotherapy cycles of larotrectinib patients with CCR or CR will continue to receive larotrectinib maintenance therapy as monotherapy for a total of 12 cycles Continuation of treatment beyond 12 cycles and up to 24 cycles may be considered for patients on Larotrectinib monotherapy if they are receiving clinical benefit from the study at the discretion of the treating physician
Patients 48 months with PR or SD after 2 cycles of larotrectinib will go on to receive combination therapy with standard backbone chemotherapy BABYPOG or HIT-SKK Patients 48 months of age or patients 36 months of age or patients with DIPG 18 months of age at the discretion of the local investigator will receive focal radiation therapy A surgical cohort study will be explored whereby patients who have had a tumor biopsypartial resection at their local institution and are planned to subsequently undergo definitive resection will receive 3-5 days 6-10 doses of larotrectinib pre-surgery
The study design of this trial requires 15 patients evaluable for disease control and for safety toxicity of larotrectinib as monotherapy The surgical cohort will enroll up to 4 patients and will count towards the total 15 evaluable patients A minimum of 6 patients will be evaluable for safety toxicity of larotrectinib in combination with standard-of-care chemotherapy or radiotherapy
Patients 48 months with PR or SD after 2 cycles of larotrectinib will go on to receive combination therapy with standard backbone chemotherapy BABYPOG or HIT-SKK Patients 48 months of age or patients 36 months of age or patients with DIPG 18 months of age at the discretion of the local investigator will receive focal radiation therapy A surgical cohort study will be explored whereby patients who have had a tumor biopsypartial resection at their local institution and are planned to subsequently undergo definitive resection will receive 3-5 days 6-10 doses of larotrectinib pre-surgery
The study design of this trial requires 15 patients evaluable for disease control and for safety toxicity of larotrectinib as monotherapy The surgical cohort will enroll up to 4 patients and will count towards the total 15 evaluable patients A minimum of 6 patients will be evaluable for safety toxicity of larotrectinib in combination with standard-of-care chemotherapy or radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None