Clinical trial NCT01158651: Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas
Official title: A Phase II Study of RAD001 (Everolimus) for Children With NeurF1 and Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas
Conditions: Glioma
Summary: The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas in children with Neurofibromatosis type 1 (NF1). Additionally, the safety of RAD001 will be studied.
The study drug, RAD001, is a drug that may act directly on tumor cells by preventing tumor cell growth and development. RAD001 has been studied in participants with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Information from these research studies suggests that RAD001 may help to shrink or slow the growth of low-grade gliomas.
In this research study, the investigators are looking to see the response of RAD001 in children with low-grade gliomas and NF1 that have either not responded to treatment or have come back after treatment. We are also looking for the highest dose of RAD001 that can be given safely in this patient population.
Interventions:
description: If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment "course" lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks).<br/>You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection.
name: RAD001 (Everolimus)
other_name: Everolimus
RAD001
type: Drug
Study arms:
design_group_description: If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment "course" lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks).<br/>You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection.
design_group_title: RAD001 (Everolimus) Active Therapy
design_group_type: Experimental
Sponsor: The University of Alabama at Birmingham
Collaborators: The University of Chicago
National Cancer Institute
University of Utah
Washington University School of Medicine
The Children's Hospital Corp.
Ann & Robert H. Lurie Children's Hospital of Chicago
The Children's Hospital of Philadelphia
Children's Hospital Los Angeles
NYU Langone Health
Children's National Research Institute
Children's Hospital & Medical Center
Drug name mappings:
name: 依维莫司
lang: CN
name: Everolimus
lang: EN
name: エベロリムス
lang: JP