Track topics on Twitter Track topics that are important to you
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.
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.
Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Children's National Medical Center
District of Columbia
Not yet recruiting
University of Alabama at Birmingham
Published on BioPortfolio: 2014-08-27T03:12:23-0400
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that...
A single-arm, one-stage phase II trial of RAD001 will be undertaken. Sixty patients will be enrolled. The target population will be patients with a diagnosis of low-grade glioma who expe...
This is an exploratory study. The purpose of the study is to determine whether escalating doses of RAD001 (everolimus) is safe and effective in patients with Lymphangioleiomyomatosis
This is a phase II, two-stage, open-label, single-agent study of the experimental drug RAD001 (everolimus) in patients with previously treated small cell lung cancer. RAD001 will be admin...
This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the applic...
The mammalian target of rapamycin (mTOR) pathway is a critical target for cancer treatment and the mTOR inhibitor everolimus (RAD001) has been approved for treatment of renal cell carcinoma (RCC). How...
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...
Gliomas are the most common malignant primary brain tumors with poor prognosis. We attempted to explore the role of CYP17A1 in glioma progression. We demonstrated that the expression of CYP17A1 was si...
Glioma is one of the most devasting tumors and confers dismal prognosis. Long noncoding RNAs(lncRNAs) have emerged as important regulators in various tumors including glioma. A classic lncRNA-H19, whi...
This study aims to investigate the utility of F-FET PET in surgical decision making in suspected glioma. A retrospective review of patients undergoing F-FET PET was performed. Previously published thr...
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.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...