AZD6244 in Children With Low-Grade Gliomas
- AZD6244 is an experimental drug designed to prevent tumor growth and shrink existing tumors. It has been studied in adults with cancer, but it has not been studied in children with cancer. Researchers want to see if AZD6244 is a safe and effective treatment for older children and young adults who have gliomas (brain tumors) that have not responded to standard treatments.
- To test the safety and effectiveness of AZD6244 in older children and young adults who have gliomas that have not responded to standard treatments.
- People between 12 and 21 years of age who have gliomas that have not responded to standard treatments.
- Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor imaging studies. Those in the study may also have their spinal fluid tested to see whether the cancer has spread to other parts of the nervous system.
- Participants will take AZD6244 as a capsule. It must be swallowed whole on an empty stomach twice a day for 28 days. Those in the study will have up to 13 cycles (4 weeks each) of treatment (1 year).
- Participants will keep a diary to record doses taken and any side effects of the treatment.
- Participants will have frequent blood tests and imaging studies.
Low Grade Glioma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma|
- To estimate the maximum tolerated dose (MTD) or recommend a Phase II dose
- To describe the toxicity profile and define the dose limiting toxicity of AZD6244 in children with recurrent or refractory low grade gliomas
- Pharmacokinetics and pharmacogenetic polymorphisms
- Immunohistochemical assays to identify BRAF aberrations and activation of the MAPK pathway
|Study Start Date:||June 2011|
|Contact: Linda L Ellison-Dejewski, R.N.||(301) firstname.lastname@example.org|
|Contact: Katherine E Warren, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Katherine E Warren, M.D.||National Cancer Institute (NCI)|