Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT00418327
Phase
PHASE1
Status
Completed

Conditions

  • Brain Stem Glioma,
  • Malignant Brain Tumor

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Key Dates

First listed
Jan 4, 2007
Start date
Jun 30, 2005
Status verified
Aug 2009

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy [ Time Frame: End of recruitment ]

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