Brain Tumor
Phase I and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
NCI-11-C-0191, NCT01386450
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Investigator(s): |
Katherine E. Warren, M.D.
Principal Investigator
Phone: 301-496-4256
Fax: 301-480-2308
warrenk@mail.nih.gov
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Linda Ellison, R.N.
Research Nurse
Phone: 301-496-8009
Fax: 301-480-8871
ellisonl@mail.nih.gov
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Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)
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Background:
- Low grade gliomas are among the most common primary CNS neoplasms of childhood
- Debulking surgery and chemotherapy are temporizing strategies that ideally allow tumor stabilization until definitive radiation may be used; radiation therapy is associated with long-term morbidity
- Patients with high risk features such as hypothalamic location and young age at diagnosis have shown overall survival as low as 60 percent at 10 years despite multimodal therapies
- AZD6244 (ARRY-142886) is a potent, selective, orally-available, and non-ATP competitive small molecule inhibitor of the mitogen-activated protein (MAP) kinase, MEK-1/2
- Overexpression of growth factors or growth factor receptors involved in the RAS/RAF/MEK/ERK pathway and activating genetic mutations of the signaling proteins may lead to uncontrolled proliferation and tumor formation
Objectives:
- Estimate the maximum tolerated dose (MTD) or recommend a Phase II dose of AZD6244 in children with recurrent or refractory low-grade glioma
- Describe the toxicity profile and define the dose limiting toxicity of AZD6244 in children with recurrent or refractory low-grade glioma
Key Eligibility Criteria:
- ≥ 12 and < 21 years of age
- Histologically confirmed diagnosis of low grade gliomas (WHO Grades I & II); patients with optic pathway gliomas are eligible with clinical and/or radiographic evidence of progression
- Karnofsky performance scale (if > 16 yrs) or Lansky performance score (if < 16 years) ≥ 60% assessed within two weeks prior to registration
- Prior therapy with radiation prior to study registration
- Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Study Outline:
- Patients will receive AZD6244 orally twice daily approximately 12 hours apart
- Four consecutive weeks will constitute one course and subsequent courses will immediately follow, with no break in the administration of the drug
- AZD6244 on an empty stomach either 1 hour before or 2 hours after meals
- AZD6244 capsules should be taken with water only
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
Reviewed: 12/14/12
Updated: 8/1/12
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