Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors
Study Purpose
This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells.
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 | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Histologically confirmed diagnosis of 1 of the following: - Glioblastoma multiforme (grade 4 astrocytoma) - Gliosarcomas.
- - Other grade 4 astrocytoma variants (e.g., giant cell) - Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery.
- - Performance status - ECOG 0-2.
- - Performance status - Karnofsky 60-100% - At least 6 months.
- - Absolute neutrophil count at least 1,500/mm^3.
- - Platelet count at least 100,000/mm^3.
- - Hemoglobin ≥ 9 g/dL.
- - Total bilirubin ≤ upper limit of normal (ULN) - AST no greater than 2.5 times ULN.
- - Creatinine no greater than 1.5 times ULN.
- - No symptomatic congestive heart failure.
- - No unstable angina pectoris.
- - No cardiac arrhythmia.
- - No inability to take oral medications.
- - No requirement for IV alimentation.
- - No active uncontrolled peptic ulcer disease.
- - No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) - No prior allergy or intolerance to dacarbazine.
- - No other active malignancy requiring treatment.
- - No other concurrent uncontrolled illness.
- - No ongoing or active infection.
- - No psychiatric illness or social situation that would preclude study compliance.
- - Not pregnant or nursing.
- - Negative pregnancy test.
- - Fertile patients must use effective contraception.
- - No prior chemotherapy for any brain tumor.
- - No prior temozolomide.
- - No prior radiotherapy for any brain tumor.
- - No other concurrent investigational agents.
- - More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection) - No prior surgical procedures affecting absorption.
- - No concurrent combination antiretroviral therapy for HIV-positive patients.
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. |
NCT00039494 |
|
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 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Paul Brown |
| Principal Investigator Affiliation | North Central Cancer Treatment Group |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
| Overall Status | Completed |
| Countries | United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma |
PILOT STUDY OBJECTIVES:
- I. Determine the maximum tolerated dose of erlotinib administered with temozolomide and radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are currently on enzyme-inducing anticonvulsant (EIAC) therapy vs.#46;no EIAC therapy.
- II. Determine the safety and tolerability of this regimen in these patients.
- III. Determine the toxic effects of this regimen in these patients.
- IV. Determine the efficacy of this regimen, in terms of 1-year survival, in these patients.
- I. Determine the response rate and time to progression in patients treated with this regimen.
- II. Determine the 6-month progression-free survival of patients treated with this regimen.
- III. Determine the toxic effects of this regimen in these patients.
Arms
Experimental: Treatment (erlotinib hydrochloride, radiation, temozolomide)
Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Drug: - erlotinib hydrochloride
Given orally
Radiation: - 3-dimensional conformal radiation therapy
Drug: - temozolomide
Given orally
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.
Status
Address
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Status
Address
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Status
Address
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Status
Address
Northeast Georgia Cancer Care LLC
Athens, Georgia, 30607
Status
Address
Rush - Copley Medical Center
Aurora, Illinois, 60504
Status
Address
Saint Joseph Medical Center
Bloomington, Illinois, 61701
Status
Address
Graham Hospital Association
Canton, Illinois, 61520
Status
Address
Memorial Hospital
Carthage, Illinois, 62321
Status
Address
Saint Anthony Memorial Hospital
Effingham, Illinois, 62401
Status
Address
Eureka Hospital
Eureka, Illinois, 61530
Status
Address
Galesburg Cottage Hospital
Galesburg, Illinois, 61401
Status
Address
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401
Status
Address
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
Status
Address
Mason District Hospital
Havana, Illinois, 62644
Status
Address
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747
Status
Address
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435
Status
Address
Kewanee Hospital
Kewanee, Illinois, 61443
Status
Address
Mcdonough District Hospital
Macomb, Illinois, 61455
Status
Address
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265
Status
Address
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265
Status
Address
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, 61265
Status
Address
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, 61265
Status
Address
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
Moline, Illinois, 61265
Status
Address
Bromenn Regional Medical Center
Normal, Illinois, 61761
Status
Address
Community Cancer Center Foundation
Normal, Illinois, 61761
Status
Address
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Status
Address
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350
Status
Address
Pekin Cancer Treatment Center
Pekin, Illinois, 61554
Status
Address
Pekin Hospital
Pekin, Illinois, 61554
Status
Address
Methodist Medical Center of Illinois
Peoria, Illinois, 61603
Status
Address
Proctor Hospital
Peoria, Illinois, 61614
Status
Address
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Status
Address
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615
Status
Address
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Status
Address
Illinois Valley Hospital
Peru, Illinois, 61354
Status
Address
Perry Memorial Hospital
Princeton, Illinois, 61356
Status
Address
Saint Margaret's Hospital
Spring Valley, Illinois, 61362
Status
Address
Valley Cancer Center
Spring Valley, Illinois, 61362
Status
Address
Carle Clinic-Urbana Main
Urbana, Illinois, 61801
Status
Address
Saint Anthony Memorial Health Center
Michigan City, Indiana, 46360
Status
Address
McFarland Clinic
Ames, Iowa, 50010
Status
Address
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722
Status
Address
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Status
Address
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Status
Address
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403
Status
Address
Mercy Hospital
Cedar Rapids, Iowa, 52403
Status
Address
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Status
Address
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325
Status
Address
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Status
Address
Mercy Capitol
Des Moines, Iowa, 50307
Status
Address
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Status
Address
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309
Status
Address
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Status
Address
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314
Status
Address
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Status
Address
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Status
Address
Community Memorial Hospital
Missouri Valley, Iowa, 51555
Status
Address
Burgess Memorial Hospital
Onawa, Iowa, 51040
Status
Address
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101-1733
Status
Address
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101
Status
Address
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104
Status
Address
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104
Status
Address
Hospital District Sixth of Harper County
Anthony, Kansas, 67003
Status
Address
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
Status
Address
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Status
Address
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Status
Address
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Status
Address
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Status
Address
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
Status
Address
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Status
Address
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
Status
Address
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
Status
Address
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
Status
Address
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
Status
Address
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
Status
Address
Associates In Womens Health
Wichita, Kansas, 67208
Status
Address
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Status
Address
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214
Status
Address
Via Christi Regional Medical Center
Wichita, Kansas, 67214
Status
Address
Wesley Medical Center
Wichita, Kansas, 67214
Status
Address
Wichita CCOP
Wichita, Kansas, 67214
Status
Address
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
Status
Address
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995
Status
Address
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106
Status
Address
Oakwood Hospital
Dearborn, Michigan, 48124
Status
Address
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
Status
Address
Hurley Medical Center
Flint, Michigan, 48502
Status
Address
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
Status
Address
Allegiance Health
Jackson, Michigan, 49201
Status
Address
Sparrow Hospital
Lansing, Michigan, 48912
Status
Address
Saint Mary's of Michigan
Saginaw, Michigan, 48601
Status
Address
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093
Status
Address
Harris, John Gilbert MD (UIA Investigator)
Alexandria, Minnesota, 56308
Status
Address
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, 56308
Status
Address
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601
Status
Address
Brainerd Medical Center Inc
Brainerd, Minnesota, 56401
Status
Address
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Status
Address
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, 55805
Status
Address
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Status
Address
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Status
Address
Etzell, Paul S MD (UIA Investigator)
Fergus Falls, Minnesota, 56537
Status
Address
Swenson, Wade II, MD (UIA Investigator)
Fergus Falls, Minnesota, 56537
Status
Address
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355
Status
Address
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Status
Address
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, 56265
Status
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Address
CentraCare Clinic
Saint Cloud, Minnesota, 56303
Status
Address
Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Status
Address
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, 55102
Status
Address
Adult and Pediatric Urology PLLP
Sartell, Minnesota, 56377
Status
Address
Woodwinds Health Campus
Woodbury, Minnesota, 55125
Status
Address
Montana Cancer Consortium CCOP
Billings, Montana, 59101
Status
Address
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
Status
Address
Saint Vincent Healthcare
Billings, Montana, 59101
Status
Address
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102
Status
Address
Billings Clinic
Billings, Montana, 59107-7000
Status
Address
Deaconess Medical Center
Billings, Montana, 59107
Status
Address
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
Status
Address
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Status
Address
Internal Medicine of Bozeman
Bozeman, Montana, 59715
Status
Address
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Status
Address
Saint Peter's Community Hospital
Helena, Montana, 59601
Status
Address
Glacier Oncology PLLC
Kalispell, Montana, 59901
Status
Address
Community Medical Hospital
Missoula, Montana, 59801
Status
Address
Montana Cancer Specialists
Missoula, Montana, 59802
Status
Address
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Status
Address
Fremont Area Medical Center
Fremont, Nebraska, 68025
Status
Address
Bryan LGH Medical Center West
Lincoln, Nebraska, 68502
Status
Address
Bryan LGH Medical Center East
Lincoln, Nebraska, 68506
Status
Address
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Status
Address
Midlands Community Hospital
Papillion, Nebraska, 68046
Status
Address
Bismarck Cancer Center
Bismarck, North Dakota, 58501
Status
Address
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Status
Address
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Status
Address
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Status
Address
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122
Status
Address
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122
Status
Address
University of Virginia
Charlottesville, Virginia, 22908
Status
Address
Welch Cancer Center
Sheridan, Wyoming, 82801
