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Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
First Received: January 24, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052208
  Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining gefitinib with radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining gefitinib with radiation therapy in treating patients who have glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: gefitinib
Radiation: radiation therapy
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study Of An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (IRESSA) [NSC# 715055] With Radiation Therapy In Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2003
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of gefitinib when given concurrently with cranial radiotherapy in patients with glioblastoma multiforme.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.
  • Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified according to whether they are concurrently receiving enzyme-inducing anticonvulsant drugs (EIACD) (yes vs no).

  • Phase I:Patients receive oral gefitinib once daily for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo cranial radiotherapy once daily 5 days a week for 6 weeks. After the completion of radiotherapy, patients continue to receive oral gefitinib once daily for 18 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II:Patient receive oral gefitinib at the MTD as in phase I. Patients undergo cranial radiotherapy as in phase I.

Patients in both phases are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients (18 enzyme-inducing anticonvulsant drug [EIACD] patients and 12 non-EIACD patients) will be accrued for phase I of this study within 2 months. A maximum of 140 patients will be accrued for phase II of this study within 10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme with areas of necrosis

    • Tumor must be supratentorial
  • Diagnosis made by surgical biopsy or excision
  • No recurrent or multifocal disease
  • No metastases detected below the tentorium or beyond the cranial vault
  • Tumor tissue and serum samples required

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • Zubrod 0-1

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Hemoglobin at least 10 g/dL (transfusions allowed)
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGPT or SGOT no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • BUN no greater than 25 mg/dL

Other:

  • No known AIDS
  • No other major medical illness or psychiatric impairment that would preclude study participation
  • No active connective tissue disorders, including lupus and scleroderma
  • No known multiple sclerosis
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy or radiosensitizers for cancers of the head and neck

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the head and neck except for T1 glottic tumors

Surgery:

  • See Disease Characteristics
  • No more than 5 weeks since prior surgery and recovered
  • No concurrent ophthalmic surgery

Other:

  • At least 30 days since prior participation in another clinical study
  • No concurrent participation in another clinical study
  • No concurrent systemic retinoids or herbal medicines
  • No concurrent drugs that induce CytP4503A4 except enzyme-inducing anticonvulsant drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052208

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8040
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Alexian Brothers Cancer Care Center
Elk Grove Village, Illinois, United States, 60007
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Union Hospital
Terre Haute, Indiana, United States, 47804
United States, Iowa
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, United States, 51555-1199
Burgess Health Center
Onawa, Iowa, United States, 51040
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70821-2511
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70140-1015
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United Hospital
Saint Paul, Minnesota, United States, 55102
United States, Nebraska
Alegent Health - Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046-4194
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1199
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States, 27533
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
United States, Virginia
Bon Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Arnab Chakravarti, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Chakravarti A, Berkey B, Robins HI, et al.: An update of phase II results from RTOG 0211: a phase I/II study of gefitinib with radiotherapy in newly-diagnosed glioblastoma multiforme. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. 2006.
Chakravarti A, Seiferheld W, Robins HI, et al.: An update of phase I data from RTOG 0211: a phase I/II clinical study of gefitinib + radiation for newly-diagnosed glioblastoma (GBM) patients. [Abstract] J Clin Oncol 22 (Suppl 14): A-1571, 124s, 2004.
Chakravarti A, Seiferheld W, Robbins I, et al.: Phase I results from RTOG BR-0211, a phase I/II study of an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), ZD 1839 (Iressa), with radiation therapy in glioblastoma multiforme (GBM). [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S329, 2003.

Study ID Numbers: CDR0000069330, RTOG-0211, RTOG-BR-0211
Study First Received: January 24, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00052208     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Gefitinib
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009