CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
RAD001 (Everolimus)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01158651
NCT01158651Phase 2Completed
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A Phase II Study of RAD001 (Everolimus) for Children With NeurF1 and Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas

University of Alabama at Birmingham·interventional·Posted Jul 8, 2010·Updated Feb 5, 2020

In Brief

A Phase 2 clinical trial evaluating RAD001 (Everolimus) for Glioma. Completed, enrolled 23 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma
CountriesUnited States
CollaboratorsBoston Children's Hospital, Children's Hospital of Philadelphia, Children's National Research Institute, Children's Hospital Medical Center, Cincinnati, National Cancer Institute (NCI), University of Chicago, University of Utah, Washington University School of Medicine, Ann & Robert H Lurie Children's Hospital of Chicago, NYU Langone Health, Children's Hospital Los Angeles

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2010
Enrollment StartJul 10, 2010
Primary CompletionSep 4, 2014
Study CompletionOct 26, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.0 years ago

Interventions

RAD001 (Everolimus)drug

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). 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.