Researchers Compare Oral Drug Treatment With IV Drug Treatment in Patients With Neurofibromatosis and Low-Grade Glioma
Phase: Recruiting
First Posted: February
Condition(s): Neurofibromatosis, Low-Grade Glioma (LGG)
NCT Number: NCT03871257 Other Study ID Number(s): ACNS1831
What Is the Purpose of This Study?
To study if the oral drug selumetinib works just as well as the standard treatment with IV carboplatin/vincristine (CV) for patients with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves).
Who Can Take Part in This Study?
People who may be eligible for this study:
- Must have neurofibromatosis type 1 (NF1).
- Must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with anything other than surgery.
- Are 2-21 years old.
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT03871257
What Will Happen During This Study?
- One group of patients will receive carboplatin IV over 60 minutes on scheduled days and vincristine IV or IV push over 1 minute on days scheduled. Patients also undergo MRI during screening and study.
- Other group takes oral medication on days 1-28. Treatment is continuous and repeats every 28 days for 27 cycles. Patients also undergo MRI throughout the trial.
Principal Investigator
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