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Clinical Trials

redarrow_small.gif Click here for available Adult Neuro-Oncology Branch Clinical Trials.
redarrow_small.gif Click here for available Pediatric Neuro-Oncology Branch Clinical Trials.

Clinical trials for patients with tumors of the central nervous system (CNS) at the Neuro-Oncology Branch emphasize "state of the art" treatment. These trials include Phases 1 and 2 studies which utilize new chemotherapeutic agents and biologic agents. Children, teenagers or adults with newly diagnosed or recurrent primary or metastatic tumors of central nervous system are potential candidates for these trials through the Neuro-Oncology Branch of the National Institutes of Health.

We try diligently to update the clinical trials information in the website. However, if you would like to obtain any information on new clinical trials that may not have been posted or is being developed or you are interested in obtaining additional information about ongoing trials, please contact our office for more details.

Neuro-Oncology Branch
National Cancer Institute
National Institutes of Health
Bloch Building, #82
9030 Old Georgetown Road
Bethesda, MD 20892
Main Phone: (301) 402-6298                                                                                                              New Patient Phone: (301) 594-6767/ (866)251-9686
Fax: (301) 480-2246

Clinical Trials Overview

Clinical protocols are designed by experts in various fields of cancer therapy, and then reviewed by an independent group of people who comprise the Institutional Review Board (IRB). Every medical center performing clinical trials must have an IRB that reviews the protocol and approves its design before the clinical trial can begin. It is a large step from the laboratory to the clinic, particularly when it comes to the discovery and testing of new cancer treatments. After extensive laboratory research of a potential new cancer treatment, an Investigational New Drug Application (IND) is filed with the Food and Drug Administration (FDA). Following FDA approval, the three phases of clinical trials may begin. As there are significantly more adults with cancer than children, Phase 1 testing usually begins in adult patients. After initial information is gathered on a new drug's safety, Phase 1 testing may begin in children with cancer.

Phase 1 Trials

The primary objectives of a Phase 1 trial are to determine the optimal dose of an experimental drug (or a standard drug which is being administered in a new way), the behavior of the drug in the human body, and the side effects or toxicities. The optimal dose is usually the maximum dose which can be tolerated. Phase 1 trials are for patients with tumors that no longer respond to standard treatment. In a Phase 1 trial, small groups of patients are treated with the same dose of a new drug. Based on how the patients tolerate the drug, small adjustments are then made in the dose and administered to another group of patients. The dose is usually increased, but in some instances the dose may have to be lowered. Patients treated on a Phase 1 study continue to receive the experimental drug only if the drug is helping the patient. If the patient's tumor continues to grow, Neuro-Oncology Branch physicians then meet with families to discuss other therapeutic options that are available.

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Phase 2 Trials

Following completion of the Phase 1 trial, the new drug is then tested in Phase 2 trials. Phase 2 trials test the ability of the drug or combination of drugs to produce measurable tumor shrinkage or stabilization of tumor growth. In a Phase 2 trial, groups of 15 to 50 patients with the same type of tumor are treated with the new drug. Only patients with tumors that no longer respond to standard treatment are eligible for treatment on a Phase 2 trial.

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Phase 3 Trials

Phase 3 trials compare two or more treatments for a particular kind of cancer. Typically an experimental treatment is compared to a standard treatment, although in some cases two standard treatments or two promising new treatments may be compared. The objective is to see if the new treatment produces better results than standard treatments. Phase 3 trials are normally randomized, meaning that patients are randomly assigned to either one or the other treatment. Phase 3 trials have more patients than Phase 1 or 2 trials, often hundreds or sometimes thousands of patients. Phase 3 trials are performed cooperatively by a large number of medical centers across the country. For patients with brain tumors, there are a number of cooperative groups in the United States, the North American Brain Tumor Consortium (NABTC), the New approaches to Brain Tumor Therapy (NABTT) and Pediatric Brain Tumor Consortium (PBTC), Children's Oncology Group (COG), Eastern Cooperative Oncolocy Group (ECOG), Radiation Therapy Oncology Group (RTOG), Southwestern Oncology Group (SWOG), and North Central Cancer Treatment Group (NCCTG). The Neuro-Oncology Branch of the National Institutes of Health does not usually perform Phase 3 testing, but does perform smaller clinical trials termed "pilot trials" which incorporate the latest information from laboratory and clinical trials into a new protocol. These pilot trials may then form the basis for the design of future cooperative-group Phase 3 trials.

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