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Clinical trials
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- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - COG-ACNS1833
Protocol Summary
- Protocol No
- COG-ACNS1833
- Principal Investigator
- Sarah Rumler
- Phase
- III
- Title
- 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)
- Associated Disease(s)
-
Brain and Spinal Cord Tumors
- Description (Summary)
- Although most LGGs are treatable, doctors want to improve treatments by reducing short-term and long-term side effects and improving patients’ quality of life during treatment. Standard carboplatin/vincristine treatment for LGG requires frequent clinic visits (weekly for much of the treatment) for almost 15 months. The drugs are given through the veins and have some side effects that may lessen a patient’s quality of life. The study doctors want to find new treatments for LGG that work just as well as CV. The pre-screening tests that you had done on APEC14B1 showed that you have an LGG that does not have a BRAFV600E mutation. Previous studies have shown that patients with LGG may benefit from a new type of treatment like the one we will test on this study.
This study looks at how well a drug called selumetinib works when given to children and young adults with LGG. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets cancer cells grow without stopping. Early studies have shown that selumetinib was successful in treating patients with LGG that came back after a first attempt at treatment. However, the use of selumetinib in patients with previously-untreated LGG is considered experimental because selumetinib has not yet been FDA approved for this type of cancer.
The study doctors want to see if selumetinib works as well as CV for getting rid of or shrinking LGGs and stopping them from coming back. They also want to know if this treatment will improve quality of life for subjects who take it. (Subjects are people who agree to take part in this study.) Finally, study doctors want to see if selumetinib will lessen long-term side effects from the disease or the treatment, such as problems with movement and coordination or vision.
The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for subjects with LGG.
Another goal of this study is to compare the effects, good and/or bad, of selumetinib versus CV in subjects with LGG to find out which is better. In this study, you will get either the selumetinib or CV. You will not get both.
In addition to the treatment goals, we would like to answer some other questions about your quality of life, how you think and learn, and your muscle strength and coordination. These research studies are described later in this form.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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