Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576117
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2020-10-03
Brief Title:
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 3 Study of Selumetinib NSC 748727 or Selumetinib in Combination With Vinblastine for Non-NF1 Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas LGGs Lacking BRAFV600E or IDH1 Mutations
Status:
RECRUITING
Status Verified Date:
2024-09
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 phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma a common type of brain cancer that has come back after prior treatment recurrent or does not respond to therapy progressive Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping Vinblastine blocks cell growth by stopping cell division and may kill cancer cells Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated doserecommended phase 2 dose MTDRP2D of selumetinib sulfate selumetinib vinblastine sulfate vinblastine for children with progressive or recurrent low-grade gliomas LGGs
II To determine if selumetinib vinblastine will lead to improved event-free survival EFS outcome compared with selumetinib alone for children with progressive or recurrent LGGs
SECONDARY OBJECTIVES
I To estimate the objective response rates and overall survival associated with treatment with selumetinib vinblastine versus single-agent selumetinib
II To estimate the difference in EFS and response rate between patients with BRAF rearranged LGG and patients with non-BRAF rearranged LGG after treatment with selumetinib vinblastine versus single-agent selumetinib
III To evaluate toxicities associated with selumetinib vinblastine and single-agent selumetinib for children with progressive or recurrent LGGs
IV To compare the quality of life among patients treated with selumetinib vinblastine and single-agent selumetinib
V To examine the vision outcomes among patients with optic pathway gliomas OPGs treated with selumetinib vinblastine and single-agent selumetinib
EXPLORATORY OBJECTIVE
I To obtain paired blood and tumor specimens for future biology studies including studies to correlate genomic drivers to response
OUTLINE This is a dose-escalation feasibility study of vinblastine sulfate in combination with selumetinib followed by a randomized efficacy study Patients in the feasibility study are assigned to Arm I while patients in the efficacy study are randomized to Arm I or Arm II
ARM I Patients receive vinblastine sulfate intravenously IV over 1 minute or IV infusion on days 1 8 15 and 22 and selumetinib sulfate orally PO twice daily BID on days 1-28 Treatment repeats every 28 days Patients receive selumetinib and vinblastine for a total duration of 17 cycles followed by 10 additional cycles of selumetinib alone in the absence of disease progression or unacceptable toxicity Patients undergo magnetic resonance imaging MRI throughout the trial Patients also undergo blood sample collection during screening and on study
ARM II Patients receive selumetinib sulfate PO BID on days 1-28 Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity Patients undergo MRI throughout the trial Patients also undergo blood sample collection during screening and on study
After completion of study treatment patients are followed up every 3 months for year 1 every 6 months for years 2-3 and annually for years 4-5
I To determine the maximum tolerated doserecommended phase 2 dose MTDRP2D of selumetinib sulfate selumetinib vinblastine sulfate vinblastine for children with progressive or recurrent low-grade gliomas LGGs
II To determine if selumetinib vinblastine will lead to improved event-free survival EFS outcome compared with selumetinib alone for children with progressive or recurrent LGGs
SECONDARY OBJECTIVES
I To estimate the objective response rates and overall survival associated with treatment with selumetinib vinblastine versus single-agent selumetinib
II To estimate the difference in EFS and response rate between patients with BRAF rearranged LGG and patients with non-BRAF rearranged LGG after treatment with selumetinib vinblastine versus single-agent selumetinib
III To evaluate toxicities associated with selumetinib vinblastine and single-agent selumetinib for children with progressive or recurrent LGGs
IV To compare the quality of life among patients treated with selumetinib vinblastine and single-agent selumetinib
V To examine the vision outcomes among patients with optic pathway gliomas OPGs treated with selumetinib vinblastine and single-agent selumetinib
EXPLORATORY OBJECTIVE
I To obtain paired blood and tumor specimens for future biology studies including studies to correlate genomic drivers to response
OUTLINE This is a dose-escalation feasibility study of vinblastine sulfate in combination with selumetinib followed by a randomized efficacy study Patients in the feasibility study are assigned to Arm I while patients in the efficacy study are randomized to Arm I or Arm II
ARM I Patients receive vinblastine sulfate intravenously IV over 1 minute or IV infusion on days 1 8 15 and 22 and selumetinib sulfate orally PO twice daily BID on days 1-28 Treatment repeats every 28 days Patients receive selumetinib and vinblastine for a total duration of 17 cycles followed by 10 additional cycles of selumetinib alone in the absence of disease progression or unacceptable toxicity Patients undergo magnetic resonance imaging MRI throughout the trial Patients also undergo blood sample collection during screening and on study
ARM II Patients receive selumetinib sulfate PO BID on days 1-28 Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity Patients undergo MRI throughout the trial Patients also undergo blood sample collection during screening and on study
After completion of study treatment patients are followed up every 3 months for year 1 every 6 months for years 2-3 and annually for years 4-5
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |
| NCI-2020-07549 | REGISTRY | None | None |
| ACNS1931 | OTHER | None | None |
| ACNS1931 | OTHER | None | None |