|
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme Clinical research trials and Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme. Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme clinical trial. Subjects frequently obtain the most expert healthcare possible for their Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme  Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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). - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArnabChakravarti, Study Chair, Massachusetts General Hospital
Cancer Treatment Center *Recruiting*
Wooster, Ohio, 44691
United States
Recruiting William Demas 330-375-3557
Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Michael Dougherty 412-232-7862
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70140-1015
United States
Recruiting Contact Person 504-903-5295
Akron General Medical Center *Recruiting*
Akron, Ohio, 44302
United States
Recruiting Mitchell Fromm 330-296-5019
Saint Alphonsus Regional Medical Center *Recruiting*
Boise, Idaho, 83706
United States
Recruiting Timothy Sawyer 208-367-3131
Pomona Valley Hospital Medical Center *Recruiting*
Pomona, California, 91767
United States
Recruiting Contact Person 909-865-9500
Bon Secours - St. Mary's Hospital *Recruiting*
Richmond, Virginia, 23226
United States
Recruiting George Trivette 804-281-8350
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Rachel Rabinovitch 720-848-0116
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting Contact Person 864-560-6747
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Bergan Mercy Medical Center *Recruiting*
Omaha, Nebraska, 68124
United States
Recruiting Contact Person 402-398-6060
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Arnab Chakravarti 617-724-1548
Mercy Hospital *Recruiting*
Coon Rapids, Minnesota, 55433
United States
Recruiting Contact Person 763-236-6000
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Gary Whipple 801-387-7400
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Contact Person 602-274-4484
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting Contact Person 712-423-2311
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
Baton Rouge General Medical Center *Recruiting*
Baton Rouge, Louisiana, 70821-2511
United States
Recruiting Contact Person 225-387-7000
Creighton University Medical Center *Recruiting*
Omaha, Nebraska, 68131-2197
United States
Recruiting Contact Person 402-280-5009
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Robert Share 708-915-6620
Pocono Cancer Center *Recruiting*
East Stroudsburg, Pennsylvania, 18301
United States
Recruiting Michael Greenberg 570-476-3488
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Walter Curran 215-955-6700
United Hospital *Recruiting*
St. Paul, Minnesota, 55102
United States
Recruiting Contact Person 864-560-6747
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
Mercy Hospital Cancer Center - Scranton *Recruiting*
Scranton, Pennsylvania, 18501
United States
Recruiting Harmar Brereton 570-348-7200
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8040
United States
Recruiting Jonathan Knisely 203-785-5702
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Tyvin Rich 434-924-9333
Alexian Brothers Cancer Care Center *Recruiting*
Elk Grove Village, Illinois, 60007
United States
Recruiting William Hartsell 847-981-5760
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Judith Figura 412-578-1923
Union Hospital *Recruiting*
Terre Haute, Indiana, 47804
United States
Recruiting Peter Garrett 317-962-3172
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68046-4194
United States
Recruiting Contact Person 402-593-3339
Lankenau Cancer Center at Lankenau Hospital *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Contact Person 610-645-2680
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Christopher Koprowski 302-733-1830
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Elizabeth Gore 414-805-4465
Ridgeview Medical Center *Recruiting*
Waconia, Minnesota, 55387
United States
Recruiting Contact Person 952-442-2191
All Saints Cancer Center at All Saints Healthcare *Recruiting*
Racine, Wisconsin, 53405
United States
Recruiting James Taylor 262-687-5000
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-357-7965
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Brenda Shank 510-456-8570
New York Methodist Hospital *Recruiting*
Brooklyn, New York, 11215
United States
Recruiting Sameer Rafla-Demetrious 718-780-3677
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0293
United States
Recruiting Mohammed Mohiuddin 859-323-6489
Mary Bird Perkins Cancer Center *Recruiting*
Baton Rouge, Louisiana, 70809
United States
Recruiting Kenneth Lo 225-767-0847
St. Vincent Hospital *Recruiting*
Green Bay, Wisconsin, 54307-3508
United States
Recruiting Gregory Cooley 414-433-8184
Frank C. Love Cancer Institute at St. Anthony Hospital *Recruiting*
Oklahoma City, Oklahoma, 73102
United States
Recruiting Marianne Young 405-272-8490
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Andy Trotti 813-972-8424
Fairview University Medical Center - University Campus *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Chung Lee 612-273-6700
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Paul Sperduto 952-993-1517
Cancer Care Center, Incorporated *Recruiting*
Salem, Ohio, 44460
United States
Recruiting Contact Person 330-375-3557
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36652-2144
United States
Recruiting Contact Person 251-435-2400
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Michael Haddock 507-284-2669
West Tennessee Cancer Center at Jackson-Madison County General Hospital *Recruiting*
Jackson, Tennessee, 38301
United States
Recruiting J.J. Kovalic 901-425-6250
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting H. Robins 608-263-1416
Memorial Hospital Cancer Center *Recruiting*
Colorado Springs, Colorado, 80909
United States
Recruiting Mark Hazuka 719-365-5800
Hubert H. Humphrey Cancer Center at North Memorial Medical Center *Recruiting*
Robbinsdale, Minnesota, 55422
United States
Recruiting Contact Person 763-520-5200
Yakima Valley Memorial Hospital *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Sean Cleary 509-574-3500
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112-2699
United States
Recruiting Ellen Zakris 504-568-5151
Moses Cone Regional Cancer Center at Wesley Long Community Hospital *Recruiting*
Greensboro, North Carolina, 27403-1199
United States
Recruiting Contact Person 336-832-1100
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting Contact Person 402-898-8044
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Daniel Petereit 605-719-2360
Alegent Health Community Memorial Hospital *Recruiting*
Missouri Valley, Iowa, 51555-1199
United States
Recruiting Contact Person 712-642-2784
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Albert DeNittis 610-645-2433
Paoli Memorial Hospital *Recruiting*
Paoli, Pennsylvania, 19301-1792
United States
Recruiting Contact Person 610-648-1637
Bryn Mawr Hospital *Recruiting*
Bryn Mawr, Pennsylvania, 19010
United States
Recruiting Contact Person 610-526-3686
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05405-0075
United States
Recruiting H. Wallace 802-656-4414
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
Alegent Health - Immanuel Medical Center *Recruiting*
Omaha, Nebraska, 68122
United States
Recruiting Contact Person 402-572-2121
Northwest Community Hospital *Recruiting*
Arlington Heights, Illinois, 60005
United States
Recruiting Contact Person 847-618-6660
Wellspan Health - York Cancer Center *Recruiting*
York, Pennsylvania, 17403
United States
Recruiting Ronald Malcom 717-741-8100
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting James Wheeler 402-354-4104
Additional Information:
Study ID Numbers: CDR0000069330; RTOG-0211,RTOG-BR-0211,RTOG-DEV-1007
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052208
Other Adult Glioblastoma Multiforme Studies:
1. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
2. Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme
3. Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
4. Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
5. Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
|
|
|
|
|
|
|
|
