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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Diagnosis of high-grade glioma of 1 of the following types: - Unfavorable low-grade glioma.
  • - Gliomatosis cerebri or bithalamic involvement.
  • - Histologically confirmed high-grade glioma (WHO grade III or IV) of 1 of the following subtypes: - Anaplastic astrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Anaplastic oligoastrocytoma.
  • - Anaplastic ganglioglioma.
  • - Pleomorphic xanthoastrocytoma with anaplastic features.
  • - Malignant glioneuronal tumor.
  • - Glioblastoma multiforme.
  • - Gliosarcoma.
  • - Newly diagnosed disease.
  • - Intracranial or spinal cord tumors allowed.
PATIENT CHARACTERISTICS: Age.
  • - 3 to 21.
Performance status.
  • - Karnofsky 40-100% (age 17 to 21 years) OR.
  • - Lansky 40-100% (age 3 to 16 years) Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Absolute neutrophil count ≥ 1,000/mm^3.
  • - Platelet count ≥ 100,000/mm^3 (transfusion independent) - Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic.
  • - Bilirubin < 1.5 times upper limit of normal (ULN) - SGPT < 5 times ULN.
  • - Albumin ≥ 2 g/dL.
Renal.
  • - Creatinine < 2 times normal OR.
  • - Glomerular filtration rate > 70 mL/min.
Cardiovascular.
  • - No significant cardiovascular problem.
Pulmonary.
  • - No significant pulmonary problem.
Other.
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception.
  • - No uncontrolled infection.
  • - No significant medical illness.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - No prior or concurrent biologic agents.
Chemotherapy.
  • - No prior or concurrent chemotherapy.
Endocrine therapy.
  • - Not specified.
Radiotherapy.
  • - No prior radiotherapy.
Surgery.
  • - No more than 42 days since prior surgery.
Other. - No other prior or concurrent anticancer or experimental treatment

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00124657
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St. Jude Children's Research Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alberto Broniscer, MD
Principal Investigator Affiliation St. Jude Children's Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Study Website: View Trial Website
Additional Details

OBJECTIVES: Primary.

  • - Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered during and after radiotherapy in young patients with newly diagnosed high-grade glioma and unfavorable low-grade glioma.
  • - Determine the 1- and 2-year progression-free survival of patients treated with this regimen.
Secondary.
  • - Determine the toxic effects of this regimen in these patients.
  • - Correlate genetic abnormalities in epidermal growth factor receptor (EGFR) and components of downstream pathways with treatment response in patients treated with this regimen.
  • - Determine the ability of erlotinib to inhibit EGFR signaling in patients with high-grade glioma who require second surgery.
  • - Determine the pharmacokinetics of erlotinib and its metabolites in these patients.
  • - Correlate plasma and cerebrospinal fluid levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor response in patients treated with this regimen.
  • - Correlate irradiation dosimetry with patterns of failure, standard and investigational imaging, and toxicity in patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of erlotinib followed by a phase II study.
  • - Phase I: Patients undergo radiotherapy once daily, 5 days week, for approximately 6½ weeks.
Beginning on the first day of radiotherapy, patients receive oral erlotinib once daily for up to 2 years. Cohorts of patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
  • - Phase II: Patients will receive erlotinib as in phase I at the MTD and undergo radiotherapy as in phase I.
PROJECTED ACCRUAL: A total of 75-80 patients (15-20 for the phase I portion and 60 for the phase II portion) will be accrued for this study.

Arms & Interventions

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.

Interventions

Drug: - Erlotinib hydrochloride

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, San Diego, California

Status

Address

University of California San Diego

San Diego, California, 92123-4282

Durham, North Carolina

Status

Address

Duke Children's Hospital and Health Center

Durham, North Carolina, 27710

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

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