Because there is no known “cure” for pediatric brain tumors, most children are treated on a clinical trial after surgery. Your doctor will advise you about the trials that are available and what might be best for your child’s type of tumor. A clinical trial is both treatment and a way to gather information to assist researchers in developing new therapies. Clinical studies are a step in the process of developing new drugs or other ways to fight disease. They are research studies conducted with people to find better ways to prevent, diagnose and treat cancer.
Sponsors of Clinical Trial
High quality clinical trials for children with brain tumors are reviewed by objective panels of doctors, a process known as peer review.
The National Cancer Institute (NCI) or the Food and Drug Administration fund most of these trials.
The NCI’s pediatric cooperative groups (networks of children’s hospitals and academic medical centers) carry out most clinical trials for children with cancer. These groups are called Children’s Cancer Group and the Pediatric Oncology Group, soon to be merged as the Children’s Oncology Group.
Some pediatric clinical trials are carried out at the National Institutes of Health Clinical Center.
Clinical Trial Phases
Phase I trials evaluate how a new drug or treatment regimen should be administered, how often, and in what dosage. New drugs must show clear evidence of great promise in the lab before being tested on people.
Phase II trials assess efficacy of treatment for particular types of cancer and give more information about safety.
Phase III trials compare promising new treatments against the best standard treatment to date. If the new treatment proves effective, it may become the new standard.
Clinical Trial Protocol – The Research Plan
The principal investigator (pediatric oncologist or neuro-oncologist) writes a detailed action plan that describes what will be done in the research study and why.
Each protocol goes through a rigorous review in the cooperative group, at the NCI, and at the hospital where patients are enrolled.
Clinical Trial Participation
Protocols specify characteristics of the patients who can enroll in a trial.
These “eligibility criteria” are necessary to draw scientific conclusions from a study, and enable doctors to learn how to protect patients and who might benefit from a treatment.
You will be asked to sign a “consent form,” indicating that you understand the nature of the research study and treatment that your child will receive.
Making the Choice – Should Your Child be in a Clinical Trial?
The National Institutes of Health (NIH) provides several reliable sources of information about clinical trials. The NIH/National Cancer Institute makes cancer clinical trial information available by phone, at 1-800-4-cancer, and through their website, cancertrials.nci.nih.gov. The NIH provides an additional online resource at clinicaltrials.gov.
The most reliable source of information about clinical trials is from the National Cancer Institute and is available by phone through 1-800-4-cancer or on line through PDQ (Physicians Data Query) on their website, cancertrials.nci.nih.gov.
On line, you can also contact www.centerwatch.com for clinical trials information.
You can also call the Children’s Brain Tumor Foundation to help you locate and sort through clinical trials information.
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