Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma



Status:Completed
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:January 24, 2007
End Date:September 4, 2018

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Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme

This phase II trial studies how well dasatinib works in treating patients with glioblastoma
multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the therapeutic efficacy of dasatinib in all patients (i.e., stages 1B and 2
combined) with recurrent/progressive glioblastoma (GBM) as measured by 6-month
progression-free survival.

SECONDARY OBJECTIVES:

I. To determine the therapeutic efficacy of dasatinib for stage 1B patients with
recurrent/progressive GBM as measured by a hybrid endpoint of 6-month progression-free
survival OR objective response of (complete response [CR] or partial response [PR]) rate.

II. To determine patient overall survival. III. To determine the toxicity of dasatinib in the
treatment of patients with GBM.

IV. To determine radiographic response rate to treatment. V. To determine patient
progression-free survival. VI. To explore molecular correlates of clinical outcome. VII. To
explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression and unacceptable toxicity.

After the completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis

- The patient must consent to submission of tissue for central pathology review

- Patients who have already undergone central pathology review through their enrollment
on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to
having their material re-reviewed by the central pathologist for this study

- All patients must consent to molecular analysis of pre-dasatinib tumor tissue

- Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5,
2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC
proto-oncogene, non-receptor tyrosine kinase [SRC], v-kit Hardy-Zuckerman 4 feline
sarcoma viral oncogene homolog [KIT], platelet-derived growth factor receptor [PDGFR],
or ephrin type-A receptor 2 [EPHA2])

- Patients accrued to stage II (cohort closed; not currently applicable) do not require
overexpression of SRC, KIT, PDGFR, or EPHA2

- History and physical examination, including height and weight, within 10 days prior to
registration on study

- Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days
prior to registration on study

- Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot
undergo MRI scanning

- Karnofsky performance status >= 60

- Absolute neutrophil count (ANC) >= 1,000 cells/mm^3

- Platelets >= 75,000 cells/mm^3

- Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to
achieve Hgb >= 8.0 g/dl is acceptable)

- Leukocytes >= 3,000 cells/mm^3

- Absolute lymphocyte count (ALC) >= 500 cells/mm^3

- Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 institutional upper limit of normal

- Creatinine =< 3 X institutional upper limit of normal or creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- All patients must have undergone prior treatment with radiotherapy and temozolomide;
no other prior treatments are allowed

- There must be unequivocal radiographic evidence for tumor progression by MRI or CT
scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period
of protocol treatment for tumor measurement; patients must be on a stable or
decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is
performed

- Patients having undergone recent surgery for recurrent/progressive disease are
eligible as long as they have recovered from the effects of surgery; patients who
recently underwent resection without measurable disease post-operatively are also
eligible

- Measurable disease is not required for eligibility in patients who recently underwent
resection as long as the following conditions are met as applicable:

- Progression of disease led to the surgery

- Gliadel wafers were not placed during the most recent surgery

- Neither convection enhanced delivery nor catheters for infusion of chemotherapy
were used during the most recent surgery

- Radioactive seeds were not placed during the most recent surgery

- The histology of the most recent surgery documented
recurrent/persistent/progressive malignant glioma

- Women of childbearing potential must have a negative beta human chorionic gonadotropin
(B HCG) pregnancy test =< 3 days prior to registration

- Patient must sign study-specific informed consent prior to study entry

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible)

- Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or
failure to recover from adverse events of either radiotherapy or temozolomide

- Patients may not be receiving any other investigational agents

- Severe, active comorbidity, defined as follows:

- Any clinically significant cardiovascular disease including the following:

- Unstable angina and/or congestive heart failure requiring hospitalization
within the past 6 months

- Transmural myocardial infarction or ventricular tachyarrhythmia within the
past 6 months

- Prolonged corrected QT interval (QTc) > 480 msec (Fridericia correction)

- Ejection fraction less than institutional normal

- Major conduction abnormality (unless a cardiac pacemaker is present)

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this protocol

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception; breastfeeding should
be discontinued if the mother is treated with dasatinib

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to dasatinib

- Patients who require concurrent treatment with any medications or substances that are
potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4
(CYP3A4) are ineligible

- Patients must not be taking hepatic enzyme inducing antiepileptic drugs (EIAEDs); if
patients were previously on EIAEDs that have been discontinued, patients must have
been off EIAEDs for >= 2 weeks prior to initiation of dasatinib

- Patients who require antacids should use short-acting, locally active agents (e.g.,
Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours
before or 2 hours after the dasatinib dose

- Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low
molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox)

- Use of ibuprofen or non-steroidal anti-inflammatory drugs (NSAIDs)

- Patients with any condition (e.g., gastrointestinal tract disease resulting in an
inability to take oral medication or a requirement for intravenous [IV] alimentation,
prior surgical procedures affecting absorption, or active peptic ulcer disease) that
impairs their ability to swallow and retain dasatinib tablets are excluded

- Prior treatment with stereotactic radiosurgery (including Gamma-Knife, Cyberknife, or
other variants) or brachytherapy
We found this trial at
185
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3850 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
(952) 993-3123
Park Nicollet Clinic - Saint Louis Park Park Nicollet Health Services is a nonprofit, integrated...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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655 West 8th Street
Jacksonville, Florida 32209
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Jupiter, Florida 33458
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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808 North 39th Avenue
Yakima, Washington 98902
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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1 Akron General Avenue
Akron, Ohio 44307
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170 North 1100 East
American Fork, Utah 84003
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Anderson, South Carolina 29621
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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155 5th St NE
Barberton, Ohio 44203
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Beech Grove, Indiana 46107
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Boca Raton, Florida 33486
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Boston, Massachusetts 02118
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Burlington, Vermont 05405
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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2600 Sixth St. SW
Canton, Ohio 44710
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1303 North Main Street
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
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9000 N. Main St.
Dayton, Ohio 45415
(937) 734-6784
Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
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1 Wyoming St,
Dayton, Ohio 45409
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Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, Ohio 45428
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405 W Grand Ave
Dayton, Ohio 45405
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
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Dearborn, Michigan 48124
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Drexel Hill, Pennsylvania
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Dunmore, Pennsylvania 18512
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Elkton, Maryland 21921
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3401 Ludington St
Escanaba, Michigan 49829
(800) 432-6049
Green Bay Oncology - Escanaba We are one of a select few physician groups in...
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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420 S Saginaw St
Flint, Michigan 48502
810-232-3522
Genesys Regional Medical Center-West Flint Campus The health care team at Genesys Downtown Flint Health...
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One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
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1600 Southwest Archer Road
Gainesville, Florida 32610
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40 V-Twin Drive
Gettysburg, Pennsylvania 17325
(717) 339-2640
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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Glendale, California 91206
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835 S. Van Buren St.
Green Bay, Wisconsin 54301
(920) 884-3135
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
(920) 884-3135
Green Bay Oncology Limited at Saint Mary's Hospital We are one of a select few...
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835 S Van Buren St
Green Bay, Wisconsin 54301
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1726 Shawano Avenue
Green Bay, Wisconsin 54303
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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Greenville, South Carolina 29615
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773 Cherry Tree Ct
Hanover, Pennsylvania 17331
(717) 633-9573
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Houston, Texas 77030
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
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Independence, Missouri 64057
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Indianapolis, Indiana 46202
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 776-5660
Green Bay Oncology - Iron Mountain We are one of a select few physician groups...
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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Jacksonville, Florida 32207
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Jacksonville, Florida 32258
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Kansas City, Missouri 64114
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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2800 Clay Edwards Dr
Kansas City, Missouri 64116
(816) 691-2000
North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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3535 Southern Blvd
Kettering, Ohio 45429
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Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Knoxville, Tennessee 37392
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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La Crosse, Wisconsin
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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Liberty, Missouri 64068
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Livonia, Michigan 48154
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500 E 1400 N
Logan, Utah 84341
(435) 716-1000
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Lubbock, Texas 79410
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