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Cancer Clinical Trials - COG-ACNS1831
Protocol Summary
- Protocol No
- COG-ACNS1831
- Principal Investigator
- Sarah Rumler
- Phase
- III
- Title
- A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
- Associated Disease(s)
-
Brain and Spinal Cord Tumors
- Description (Summary)
- Although most LGGs are treatable and curable, patients with NF1-associated LGG have a higher chance of getting LGG in their optic pathway or brainstem. This can lead to vision loss in one or both eyes or a difficulty in moving certain parts of one’s body. Study doctors want to find treatments that will be better at getting rid of or shrinking NF1-associated LGGs and stopping them from coming back. One thing they want to do is try using different anti-cancer drugs. A drug that will be used on this study is called selumetinib. Early studies have shown that selumetinib was successful in treating patients with NF1-associated LGG that came back after a first attempt at treatment.
The standard treatment carboplatin and vincristine for NF1-associated LGG requires frequent 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 see if using selumetinib will be just as good as treatment with carboplatin/vincristine (CV) in helping to get rid of or shrink LGGs. They also want to know if selumetinib will be better than CV in improving vision in subjects whose LGG has caused vision problems (subjects are people who agree to take part in this study). Finally, the study doctors want to see if selumetinib improves a subject’s quality of life compared to CV.
Selumetinib is a drug that works by blocking proteins (a basic building block of the human body) needed for cell growth and killing cancer cells. The use of selumetinib in the treatment of previously untreated NF1-associated LGG is considered experimental because selumetinib has not yet been FDA approved for this type of cancer.
The overall goals of this study are to see if selumetinib works just as well as the standard treatment of CV for subjects with NF1-associated LGG, and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway.
Other goals of this study include:
To compare the effects, good and/or bad, of selumetinib versus CV in subjects with NF1-associated 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 vision, quality of life, and muscle strength. These research studies are described later in this form.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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