At a glance
ClinicalIndex Comparison Record- ✓Age 2-21 years at enrollment
- ✓Body surface area >= 0.5 m^2
- ✓Non-NF1 low-grade glioma without BRAFV600E mutation confirmed by central pathology review
- ✓Only surgery prior treatment allowed; no chemotherapy, radiation, or other modality except surgical resection
- ✕Prior chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant
- ✕LITT (laser interstitial thermal therapy) is permitted but other prior surgical intervention excluded
- ✕Concurrent malignancy or non-surgical treatment for another tumor within past year
- ✕Diffuse intrinsic pontine glioma with >2/3 pons involvement on MRI
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
In Brief
A Phase 3 clinical trial evaluating Biospecimen Collection, Carboplatin, and 5 other interventions for Low Grade Astrocytoma and 5 related conditions. Currently recruiting, targeting 170 participants across 132 sites in 3 countries.
Detailed Summary
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.
Study Details
Timeline
Arms & Interventions
INDUCTION: Patients receive vincristine sulfate IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial. MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and MRI throughout the trial.
Patients receive selumetinib sulfate PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at baseline and undergo collection of blood and MRI throughout the trial.
Interventions
Undergo blood sample collection
Given IV
Undergo ECHO
Undergo MRI
Ancillary studies
Given PO
Given IV