A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:July 16, 2009
End Date:November 15, 2016

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A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer

This randomized phase II trial studies cisplatin and etoposide to see how well they work when
given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12
(cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in
chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies,
such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is
not yet known whether giving cisplatin and etoposide are more effective when given together
with vismodegib or cixutumumab in treating small cell lung cancer.

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival (PFS) of patients with extensive stage small
cell lung cancer (SCLC-ED) treated with cisplatin and etoposide (CE), CE with hedgehog (HH)
inhibitor GDC-0449 (vismodegib), and CE with insulin-like growth factor-1 receptor (IGF-1R)
monoclonal antibody (IMC-A12) (cixutumumab).

SECONDARY OBJECTIVES:

I. To evaluate response rate, overall survival, and toxicity for each arm. II. To explore
putative correlates of clinical benefit from combination therapy in tumor and circulating
tumor cells in patients treated on this protocol.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A (CE): Patients receive cisplatin (75 mg/m^2) intravenously (IV) over 1-2 hours on day 1
and etoposide (100 mg/m^2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for
4 courses in the absence of disease progression or unacceptable toxicity.

ARM B (CE +GDC-0449): Patients receive cisplatin and etoposide as in Arm A and vismodegib
(GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every
21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive vismodegib alone QD in the absence of disease progression or
unacceptable toxicity.

ARM C (CE + IMC-A12): Patients receive cisplatin and etoposide as in Arm A and cixutumumab
(IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients then receive
cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 1 year.

Inclusion Criteria:

- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Extensive stage SCLC

- Extensive stage disease: the extensive disease classification for this protocol
includes all patients with disease sites not defined as limited stage; limited
stage disease category includes patients with disease restricted to one
hemithorax with regional lymph node metastases, including hilar, ipsilateral and
contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive
disease patients are defined as those patients with extrathoracic metastatic
disease, malignant pleural effusion, bilateral or contralateral supraclavicular
adenopathy

- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
baseline measurements and evaluations of all sites of disease must be obtained =< 4
weeks prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelets >= 100,000/mm^3

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

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine
aminotransferase (ALT) (serum glutamate pyruvate transaminase) =< 3 x institutional
ULN (=< 5 x ULN if liver function test [LFT] elevations are due to liver metastases)

- Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2
for patients with creatinine levels > 1.5 x institutional ULN

- Leukocytes >= 3,000/mm^3

- Hemoglobin >= 9 g/dL

- Fasting serum glucose < 120 mg/dL or below institutional ULN =< 7 days prior to
protocol randomization

- Patients with central nervous system (CNS) metastases will be eligible if they have
completed a course of CNS radiotherapy and have stable neurologic function for a
minimum of 28 days prior to study randomization; radiotherapy must have been completed
a minimum of 28 days prior to randomization, and patients must have recovered from any
adverse events related to the radiotherapy (except alopecia and grade 1 neuropathy)
and have stable neurologic function for a minimum of 28 days prior to study
randomization

- NOTE: the use of prophylactic cranial irradiation (recommended dose 25 Gy) in
those who completed protocol chemotherapy and have a response (in the absence of
progressive disease [PD]) is allowed; for patients on Arms B and C, GDC-0449 and
IMC-A12 will be held while patient is receiving prophylactic cranial irradiation
(PCI); these agents can be reinstituted after PCI is completed

- Women of child-bearing potential (WCBP) and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation

- WCBP must agree to use two reliable forms of contraception simultaneously or to
practice complete abstinence from heterosexual intercourse; the two methods of
reliable contraception must include one highly effective method (i.e.,
intrauterine device [IUD], hormonal [birth control pills, injections, or
implants], tubal ligation, partner?s vasectomy) and one additional effective
(barrier) method (i.e., latex condom, diaphragm, cervical cap); WCBP must be
referred to a qualified provider of contraceptive methods if needed

- NOTE: the WCBP randomized to Arm B must agree to use two reliable forms of
contraception simultaneously or to practice complete abstinence from
heterosexual intercourse during the following two additional time periods
related to this study: 1) while participating in the study; and 2) for at
least 12 months after discontinuation from the study

- Before starting the study drugs, all WCBP must have a negative pregnancy test
(sensitivity of at least 50 mIU/mL); the pregnancy test must be performed within
10-14 days prior to randomization

- NOTE: the WCBP randomized to Arm B must have a second pregnancy test
performed within the 24 hours prior to the start of the GDC-0449; the
subject may not receive GDC-0449 until the investigator has verified that
the results of these pregnancy tests are negative

- The WCBP randomized to Arm B will be warned that sharing the study drug is
prohibited and will be counseled about pregnancy precautions and potential risks
or fetal exposure; she must also agree to abstain from donating blood during
study participation and at least 12 months after discontinuation from the study
drug

- NOTE: male subjects randomized to Arm B must agree to use a latex condom
during sexual contact with WCBP while participating in the study and for at
least 12 months following discontinuation from the study even if he has
undergone a successful vasectomy

- Male subjects randomized to Arm B will be warned that sharing study drug is
prohibited and will be counseled about pregnancy precautions and potential risks
of fetal exposure; male subjects must agree to abstain from donating blood,
semen, or sperm during study participation and for at least 3 months after
discontinuation from the study drug

Exclusion Criteria:

- Pregnant or breastfeeding; all WCBP must have a blood test within 10-14 days prior to
randomization to rule out pregnancy

- Prior chemotherapy or biologic therapy for SCLC; patients with prior radiation may be
eligible or after palliative radiotherapy for other sites of disease; patients
receiving prior radiation cannot start therapy within 14 days after completion of
radiation, and must have recovered from adverse events attributed to radiation; no
previous irradiation to the only site of measurable or evaluable disease, unless that
site had subsequent evidence of progression

- Receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to GDC-0449 and IMC-A12 or other agents used in the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris,
uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy

- Poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are
allowed to participate, provided that their blood glucose is within normal range
(fasting < 120 mg/dL or below institutional upper limit of normal) and that they are
on a stable dietary or therapeutic regimen for this condition

- Patients with major surgery, hormonal therapy (other than replacement), within 4 weeks
prior to entering the study or those who have not recovered from adverse events

- Prior treatment with other agents targeting the IGFR or the Hedgehog signaling pathway
We found this trial at
302
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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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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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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777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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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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Adrian, Michigan 49221
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818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
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Albuquerque, New Mexico 87110
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Albuquerque, New Mexico 87102
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Allentown, Pennsylvania 18103
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1111 Duff Ave
Ames, Iowa 50010
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5301 McAuley Drive
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Ann Arbor, Michigan 48106
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
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6701 N Charles St
Baltimore, Maryland 21204
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
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205 Palmer Ave.
Bellefontaine, Ohio 43311
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Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bettendorf, Iowa 52722
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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Boca Raton, Florida 33486
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Butler, Pennsylvania 16001
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Canton, Illinois 61520
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
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Canton, Ohio 44708
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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Charleston, West Virginia 25304
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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Chicago, Illinois 60657
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303 East Superior Street
Chicago, Illinois 60611
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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Clifton Park, New York 12065
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, Ohio 43222
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
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5201 Harry Hines Blvd
Dallas, Texas 75235
(214) 590-8000
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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Dearborn, Michigan 48124
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Decatur, Georgia 30033
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Decatur, Illinois 62526
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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561 W. Central Avenue
Delaware, Ohio 43015
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Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
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Denver, Colorado 80218
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, Iowa 50307
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
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700 E University Ave
Des Moines, Iowa 50316
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
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Duluth, Minnesota 55805
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Easton, Maryland 21601
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900 W. Clairemont Ave.
Eau Claire, Wisconsin 54701
715 839-3956
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
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700 West Central
El Dorado, Kansas 67042
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155 E. Brush Hill Road
Elmhurst, Illinois 60126
(331) 221-1000
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Elyria, Ohio 44035
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501 E. Hampden Ave.
Englewood, Colorado 80113
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Ephrata, Pennsylvania 17522
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