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Study of RAD001 (Everolimus) for Children With NF1 and Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas

2014-08-27 03:12:23 | BioPortfolio

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 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.

Description

After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. These tests and procedures are likely to be part of regular glioma care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.

A medical history, which involves questions about your health history, any medications you are taking or plan to take, and any allergies.

A physical exam, during which you will be asked about any problems that you might be having. Additionally, your clinician will check your vital signs (body temperature, heart rate, breathing rate, and blood pressure) and bodily systems (respiratory, nervous, digestive, etc). The doctor will also evaluate your performance status, which indicates how much your illness affects your activity level.

Blood tests, including tests to measure any effects of your disease. Approximately 1-2 teaspoons of blood will be drawn for these tests.

Urine test, which will be done to make sure your kidneys are functioning properly.

An assessment of your tumor using scans of the brain. MRI (Magnetic Resonance Imaging) will be used to look at and evaluate the tumor.

An Electrocardiogram (ECG), which measures the electrical activity of your heart

A pregnancy test for females of childbearing potential. A small amount of blood (about half a teaspoon) or urine will be drawn for this test.

If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

Study Design

Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Glioma

Intervention

RAD001 (Everolimus)

Location

Children's National Medical Center
Washington
District of Columbia
United States
20010

Status

Not yet recruiting

Source

University of Alabama at Birmingham

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:23-0400

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Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia

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PubMed Articles [483 Associated PubMed Articles listed on BioPortfolio]

Attenuation of everolimus-induced cytotoxicity by a protective autophagic pathway involving ERK activation in renal cell carcinoma cells.

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Small cell lung cancer (SCLC) is a highly malignant cancer with few targeted therapies. In the study, by mining the Cancer Cell Line Encyclopedia (CCLE) database, we found that PI3K/AKT/mTOR pathway w...

Prediction of Tacrolimus Exposure by CYP3A5 Genotype and Exposure of Co-Administered Everolimus in Japanese Renal Transplant Recipients.

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Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.

Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. In a multicenter noninferiority tr...

Medical and Biotech [MESH] Definitions

A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.

A malignant BRAINSTEM neoplasm of the PONS. They are more commonly found in children than adults.

A BRAIN-specific hyalectin that may play a role in terminally differentiating NEURONS. It is found highly overexpressed in primary BRAIN TUMORS and in experimental models of GLIOMA.

Rare, slow-growing, benign intraventricular tumors, often asymptomatic and discovered incidentally. The tumors are classified histologically as ependymomas and demonstrate a proliferation of subependymal fibrillary astrocytes among the ependymal tumor cells. (From Clin Neurol Neurosurg 1997 Feb;99(1):17-22)

Neoplasms located in the brain ventricles, including the two lateral, the third, and the fourth ventricle. Ventricular tumors may be primary (e.g., CHOROID PLEXUS NEOPLASMS and GLIOMA, SUBEPENDYMAL), metastasize from distant organs, or occur as extensions of locally invasive tumors from adjacent brain structures.

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