Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Study Purpose
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 glioblastoma multiforme (GBM) or gliosarcoma.
- - Newly diagnosed by surgical biopsy or excision within the past 5 weeks.
- - Supratentorial location, as determined by the following: - Contrast-enhanced MRI performed preoperatively.
- - MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery) - Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed.
- - No gliomas graded < GBM.
- - No recurrent malignant gliomas.
- - No tumor foci detected below the tentorium or beyond the cranial vault.
- - No multifocal disease or leptomeningeal spread.
- - Zubrod performance status 0-1.
- - Neurologic function status 0-2.
- - Absolute neutrophil count ≥ 1,800 cells/mm^3.
- - Platelet count ≥ 100,000 cells/mm^3.
- - Hemoglobin ≥ 8 g/dL (transfusion allowed) - BUN ≤ 25 mg/dL.
- - Creatinine ≤ 1.5 mg/dL.
- - Bilirubin ≤ 1.5 mg/dL.
- - ALT or AST ≤ 2 times upper limit of normal.
- - Fertile patients must use effective contraception during and for 2 months after completion of study treatment.
- - Negative pregnancy test.
- - Not pregnant or nursing.
- - No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years.
- - No severe, active comorbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months.
- - Transmural myocardial infarction within the past 6 months.
- - Acute bacterial or fungal infection requiring intravenous antibiotics at study entry.
- - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry.
- - Coagulation defects.
- - Known AIDS.
- - No prior allergic reaction to the study drugs.
- - No history of porphyria or G6PD deficiency.
- - No allergy to gadolinium or contraindications to MRI.
- - No other concurrent chemotherapy.
- - Recovered from effects of surgery or postoperative infection and other complications.
- - No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM.
- - Prior chemotherapy for a different cancer allowed.
- - No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields.
- - No prophylactic filgrastim (G-CSF) during the first course of study treatment.
Trial Details
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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. |
NCT00305864 |
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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 1/Phase 2 |
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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) |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
David Brachman |
| Principal Investigator Affiliation | Radiation Therapy Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH, Other |
| Overall Status | Completed |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma |
PRIMARY OBJECTIVES:
- I. Determine the maximum tolerated dose of motexafin gadolinium (MGd) when given concurrently with temozolomide and radiotherapy in patients with newly diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma.
- II. Estimate the overall survival of patients treated with concurrent radiotherapy, temozolomide, and MGd followed by post-radiation temozolomide.
- III. Determine the short- and long-term adverse effects in patients treated with this treatment.
- IV. Estimate the progression-free survival of patients with newly diagnosed supratentorial GBM or gliosarcoma treated with this regimen.
- I. Patients also receive MGd as in phase I at the MTD determined in phase I.
Arms
Experimental: Phase I: MGd 3 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Phase I: MGd 4 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40.Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Phase I: MGd 5 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Active Comparator: Phase II: MGd 5 mg/kg
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Radiation: - 3-Dimensional Conformal Radiation Therapy
Undergo radiotherapy
Drug: - Motexafin Gadolinium
Given IV
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
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Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260
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The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724
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East Bay Radiation Oncology Center
Castro Valley, California, 94546
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Eden Hospital Medical Center
Castro Valley, California, 94546
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Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
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Address
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
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Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538
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Saint Rose Hospital
Hayward, California, 94545
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Los Angeles County-USC Medical Center
Los Angeles, California, 90033
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
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Contra Costa Regional Medical Center
Martinez, California, 94553-3156
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El Camino Hospital
Mountain View, California, 94040
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Highland General Hospital
Oakland, California, 94602
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Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
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Bay Area Tumor Institute
Oakland, California, 94609
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Hematology and Oncology Associates-Oakland
Oakland, California, 94609
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Tom K Lee Inc
Oakland, California, 94609
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Address
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
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Address
Valley Care Health System - Pleasanton
Pleasanton, California, 94588
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Address
Valley Medical Oncology Consultants
Pleasanton, California, 94588
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Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806
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Address
Denver Veterans Administration Medical Center
Denver, Colorado, 80220
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Address
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
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Address
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
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Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Address
Rush - Copley Medical Center
Aurora, Illinois, 60504
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Address
Saint Joseph Medical Center
Bloomington, Illinois, 61701
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Address
Graham Hospital Association
Canton, Illinois, 61520
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Address
Memorial Hospital
Carthage, Illinois, 62321
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Address
Heartland Cancer Research NCORP
Decatur, Illinois, 62526
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Address
Eureka Hospital
Eureka, Illinois, 61530
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Address
Galesburg Cottage Hospital
Galesburg, Illinois, 61401
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Address
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
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Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
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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
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Kewanee Hospital
Kewanee, Illinois, 61443
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Mcdonough District Hospital
Macomb, Illinois, 61455
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Address
Bromenn Regional Medical Center
Normal, Illinois, 61761
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Address
Community Cancer Center Foundation
Normal, Illinois, 61761
Status
Address
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
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Address
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350
Status
Address
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554
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Pekin Hospital
Pekin, Illinois, 61554
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Address
Methodist Medical Center of Illinois
Peoria, Illinois, 61603
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Proctor Hospital
Peoria, Illinois, 61614
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Address
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
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Address
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
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OSF Saint Francis Medical Center
Peoria, Illinois, 61637
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Address
Illinois Valley Hospital
Peru, Illinois, 61354
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Valley Radiation Oncology
Peru, Illinois, 61354
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Address
Perry Memorial Hospital
Princeton, Illinois, 61356
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Address
Saint Margaret's Hospital
Spring Valley, Illinois, 61362
Status
Address
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, 46320
Status
Address
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Status
Address
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360
Status
Address
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Status
Address
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
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Address
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
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Address
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124
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Address
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
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Address
Hurley Medical Center
Flint, Michigan, 48503
Status
Address
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
Status
Address
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Status
Address
Allegiance Health
Jackson, Michigan, 49201
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Address
Sparrow Hospital
Lansing, Michigan, 48912
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Address
Saint Mary Mercy Hospital
Livonia, Michigan, 48154
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Address
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341
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Address
Lake Huron Medical Center
Port Huron, Michigan, 48060
Status
Address
Saint Mary's of Michigan
Saginaw, Michigan, 48601
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Address
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093
Status
Address
Mercy Hospital-Joplin
Joplin, Missouri, 64804
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Address
CHI Health Good Samaritan
Kearney, Nebraska, 68847
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Address
John F Kennedy Medical Center
Edison, New Jersey, 08818
Status
Address
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
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Address
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Status
Address
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607
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Address
Rex Cancer Center
Raleigh, North Carolina, 27607
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Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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Address
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
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Address
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
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Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
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Address
Temple University Hospital
Philadelphia, Pennsylvania, 19140
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Address
Reading Hospital
West Reading, Pennsylvania, 19611
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Address
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
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Address
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096
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Address
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, 78209
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Address
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, 78229
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Address
University Hospital
San Antonio, Texas, 78229
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Address
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Address
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
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Address
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
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Address
Cottonwood Hospital Medical Center
Murray, Utah, 84107
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Address
Intermountain Medical Center
Murray, Utah, 84107
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Address
McKay-Dee Hospital Center
Ogden, Utah, 84403
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Address
Utah Valley Regional Medical Center
Provo, Utah, 84604
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Address
Dixie Medical Center Regional Cancer Center
Saint George, Utah, 84770
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Address
Intermountain Health Care
Salt Lake City, Utah, 84103
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Address
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106
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Address
LDS Hospital
Salt Lake City, Utah, 84143
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Address
University of Washington Medical Center
Seattle, Washington, 98195
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Address
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003
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Address
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
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Address
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
