Erlotinib Alone or in Combination With Radiation Therapy in Treating Young Patients With Refractory or Relapsed Malignant Brain Tumors or Newly Diagnosed Brain Stem Glioma
NCT00360854 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2013-09-20
Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed brain stem glioma.
Conditions
Interventions
- DRUG
-
erlotinib hydrochloride
- GENETIC
-
mutation analysis
- GENETIC
-
polymorphism analysis
- OTHER
-
laboratory biomarker analysis
- OTHER
-
pharmacological study
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
Children's Cancer and Leukaemia Group
lead OTHER
Principal Investigators
-
Darren Hargrave, MD · Royal Marsden NHS Foundation Trust
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 1 Year
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
Countries
- Ireland
- United Kingdom
Study Locations
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