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


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Cerebral Gigantism

 




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

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2005

Sponsors and Collaborators: St. Jude Children''''s Research Hospital
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00124657

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 patients with newly diagnosed glioma.

Condition Intervention Phase
adult brain tumor
Childhood Oligodendroglioma
high-grade childhood cerebral astrocytoma
low-grade childhood cerebral astrocytoma
untreated childhood cerebellar astrocytoma
 Drug: erlotinib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Procedure: protein tyrosine kinase inhibitor therapy
 Procedure: radiation therapy
 Procedure: radiosensitization
Phase I
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: A Phase I/II Study of Erlotinib and Radiotherapy in Young Patients With Newly Diagnosed Intracranial High-Grade Glioma or Unfavorable Low-Grade Glioma

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a phase I dose-escalation study of erlotinib followed by a phase II study.

  • 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 52 weeks. 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.

Eligibility

Ages Eligible for Study:  3 Years   -   25 Years,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of intracranial 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

PATIENT CHARACTERISTICS: Age

  • 3 to 25

Performance status

  • Karnofsky 40-100% (age 17 to 25 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

Pulmonary

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 prior or other concurrent anticancer or experimental treatment
  • At least 7 days since prior enzyme-inducing anticonvulsants

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00124657


Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Alberto Broniscer, MD  901-495-5007 

Study chairs or principal investigators

Alberto Broniscer, MD,  Study Chair,  St. Jude Children''''s Research Hospital   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000437085; SJCRH-SJHG04; GENENTECH-OSI3160s
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124657
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02

Resources



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December 1, 2009



Page Updated: September 6, 2005
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