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

Sponsor
Children's Cancer and Leukaemia Group
Study ID
NCT00360854
Phase
PHASE1
Status
Unknown

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
  • mutation analysis — GENETIC
  • polymorphism analysis — GENETIC
  • laboratory biomarker analysis — OTHER
  • pharmacological study — OTHER
  • radiation therapy — RADIATION

Study Details

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.

Key Dates

First listed
Aug 7, 2006
Start date
May 31, 2005
Status verified
Jun 2007

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy

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