Study of Carboplatin and Vincristine vs. Selumetinib in Newly Diagnosed or Previously Untreated Low-Grade Glioma Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1
A Phase III Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
About
Protocol Description
Low-grade gliomas (LGGs) are the most common central nervous system tumors in children. Although surgical resection is the mainstay of therapy, complete resection can be difficult due to tumor location and can lead to adverse effects.
Radiation therapy is an effective treatment for LGGs but can cause serious side effects, such as second cancers. Therefore, most experts agree that the first-line standard of care for LGGs that require treatment is chemotherapy, specifically with classic chemotherapy like carboplatin and vincristine (CV).
Since the vast majority of patients will not succumb to their disease, treatment is often focused on improving progression-free survival and minimizing the impact on areas such as functional/behavioral outcomes and quality of life.
COG# ACNS1833
Eligibility Criteria
Inclusion Criteria
- Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation.
- No prior treatment besides surgery. Note: Patients may be newly-diagnosed or previously diagnosed, and there is no required timeframe between biopsy/surgery and treatment initiation.
- Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible.
- Patients must have two-dimensional measurable tumor ≥ 1 cm2 to be eligible.
- Patients must be ≥ 2 years and ≤ 21 years at the time of enrollment.
- Patients must have a body surface area (BSA) of ≥ 0.5 m2 at enrollment.
- Patients must have adequate renal, liver, cardiac and bone marrow function as defined the by protocol.
- Patients with a known seizure disorder should be stable.
Exclusion Criteria
- No prior therapy: Patients must not have received any prior tumor-directed therapy, including chemotherapy, radiation therapy, immunotherapy or bone marrow transplant. Prior surgical intervention is permitted.
- Patients may not be receiving any other investigational agents.
See Protocol Section 3 for a complete comprehensive list of inclusion and exclusion criteria.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. He has over 30 years of clinical experience and is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, C.C.R.P.
Clinical Research Coordinator II
