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| 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 |
| Study Start Date: | June 2003 |
OBJECTIVES:
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).
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme with areas of necrosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Arnab Chakravarti, MD | Massachusetts General Hospital |
More Information
| 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 |
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
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 |