Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT00124657
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib hydrochloride — DRUG
    This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).

Study Details

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.

Key Dates

First listed
Jul 28, 2005
Start date
Mar 31, 2005
Status verified
Oct 2015
Primary completion
Jul 31, 2012
Completion
Sep 30, 2014

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with High-Grade/Low-Grade Glioma
    Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and \<26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicity (DLT) [ Time Frame: During the first 8 weeks of therapy ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92123-4282-
Duke Children's Hospital and Health CenterDurhamNorth Carolina27710-
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in San Diego, CA

By research site
University of California San Diego· San Diego, CADuke Children's Hospital and Health Center· Durham, NCSt. Jude Children's Research Hospital· Memphis, TN

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