Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:2/21/2019
Start Date:May 8, 2017
End Date:June 30, 2027

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A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide,
or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active
surveillance may help doctors to monitor subjects with low risk germ cell tumors after their
tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and
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.

PRIMARY OBJECTIVES:

I. To evaluate whether a strategy of complete surgical resection followed by surveillance can
maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent
and adult patients (ages 0 to < 50 years) with stage I (low risk) malignant germ cell tumors,
and at least 95% for patients with ovarian pure immature teratoma.

II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen
in the treatment of pediatric, adolescent and young adult patients with standard risk germ
cell tumors.

III. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin [C]
etoposide [E] bleomycin [b]) vs. a cisplatin-based regimen (cisplatin [P]Eb) in children
(less than 11 years in age) with standard risk germ cell tumors (GCT).

IV. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen
(BEP) in adolescents and young adults (ages 11 - < 25 years) with standard risk GCT.

SECONDARY OBJECTIVES:

I. To compare the incidence of ototoxicity in children, adolescents and young adults with
standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to
cisplatin-based chemotherapy.

II. To refine and validate a novel patient-reported measure of hearing outcomes for children,
adolescents and young adults with standard risk germ cell tumors.

EXPLORATORY OBJECTIVES:

I. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein [FP]
and beta-human chorionic gonadotropin [HCG]) with clinical outcome in low and standard risk
germ cell tumor patients.

II. To compare self-reported peripheral neuropathy and other patient-reported outcomes
between children, adolescents and young adults with standard risk germ cell tumors treated
with carboplatin-based chemotherapy as compared to cisplatin based chemotherapy.

III. Assess the relationship between hearing loss as measured by audiometry with the effects
of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS)
instrument.

OUTLINE:

Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I malignant germ
cell tumors undergo observation and can transfer to standard risk arm when eligibility
criteria are met.

Patients with standard risk 1 are randomized into 1 of 2 arms.

ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV
over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5.
Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity.

ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive
etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats
every 21 days for up to 4 courses in the absence of disease progression or unacceptable
toxicity.

Patients with standard risk 2 are randomized into 1 of 2 arms.

ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide
IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.

ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, 15, etoposide IV
over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats
every 21 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up monthly to 12 months, every 2
months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

Inclusion Criteria:

- Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all
sites]): Patients must be < 50 years of age at enrollment

- Standard risk 1: Patient must be < 11 years of age at enrollment

- Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment

- Newly diagnosed patients must have histologic verification of a primary extracranial
germ cell tumor in any of the categories outlined; elevation of serum tumor markers
without histologic confirmation is not sufficient for entry on the trial

- NOTE: for low risk patients, materials for rapid surgical central review must be
sent within 7 days of study enrollment

- Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology
Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB;
grade: 2 or 3; histology: pure immature teratoma (may contain =< 5% of microscopic
yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of
mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG
institutional normal; age (years) < 50

- Low risk stage I MCGT; site: ovarian, testicular, or extragonadal; stage: COG stage I,
FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA,
IB and IS; histology: must contain at least one of the following: yolk sac tumor,
embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 50

- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage
II-IV, FIGO stage IC, FIGO stage II-IV; histology: must contain at least one of the
following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed);
age (years) < 11

- Standard risk 2 (SR2)

- Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology:
must contain at least one of the following: yolk sac tumor, embryonal carcinoma,
or choriocarcinoma (pure or mixed); age (years) >= 11 and < 25

- Site: testicular; stage: COG stage II-IV, AJCC stage II, III, International Germ
Cell Consensus Classification (IGCCC) good risk; histology: must contain at least
one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma
(pure or mixed); tumor markers: must be IGCCC good risk; post op: alpha-FP <
1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x
normal; age (years) >= 11 and < 25

- Site: extragonadal; stage: COG stage II; histology: must contain at least one of
the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or
mixed) age (years) >= 11 and < 25

- Notes:

- IGCCC criteria only apply to SR2 patients with a testicular primary tumor

- Use post-op tumor marker levels to determine IGCCC risk group

- For the low risk stage I MGCT and the standard risk arms, components of yolk sac
tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of
GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the
only malignant component present, then it must be deemed by the pathologist to be
greater than a ?microscopic component? of yolk sac tumor (i.e. > 5%)

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age

- Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1
and SR2 patients)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2

- A serum creatinine based on age/gender as follows: (mg/dL)

- 1 month to < 6 months male: 0.4 female: 0.4

- 6 months to < 1 year male: 0.5 female: 0.5

- 1 to < 2 years male: 0.6 female: 0.6

- 2 to < 6 years male: 0.8 female: 0.8

- 6 to < 10 years male: 1 female: 1

- 10 to < 13 years male: 1.2 female: 1.2

- 13 to < 16 years: male: 1.5 female: 1.4

- >= 16 years male: 1.7 female: 1.4

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

- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT
is 45 U/L)

- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if
there is clinical indication or determination; pulmonary function tests (PFTs) are not
required

- Eligibility criteria to participate in the pilot study of the AYA-Hears instrument
(patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will
not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be
enrolled on the AGCT1531 SR2 arm in order to participate

- >= 11 and < 25 years old at enrollment

- Able to fluently speak and read English

- Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy
including diagnoses other than germ cell tumor

- Followed for cancer or survivorship care at one of the following institutions:

- Dana Farber/Harvard Cancer Center

- Hospital for Sick Children

- Children?s Hospital of Eastern Ontario

- Oregon Health and Science University

- Seattle Children?s Hospital

- Yale University

- Has experienced prior or ongoing hearing impairment due to chemotherapy or
radiotherapy as defined by one of the following:

- Society of Pediatric Oncology (SIOP) grade 1 hearing loss

- Subjective (patient-reported) hearing difficulties

- Subjective (patient-reported) tinnitus

Exclusion Criteria:

- Patients with any diagnoses not listed including:

- Stage I testicular cancer patients who have undergone primary RPLND
(retroperitoneal lymph node dissection)

- Pure dysgerminoma and pure seminoma

- Pure mature teratoma

- Pure immature teratoma COG stage I, grade I

- Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >=
1000 ng/mL

- Pure immature teratoma COG stage II - IV or FIGO stage IC to IV

- "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or
IV EG, or IGCCC intermediate or poor risk testicular), or

- Primary central nervous system (CNS) germ cell tumor

- Patients must have had no prior systemic therapy

- Patients must have had no prior radiation therapy with the exception of CNS
irradiation of brain metastases; (this exception only applies to SR1 patients; any
patients over age 11 with distant metastases to brain [stage IV disease] would be
considered poor risk and therefore not eligible for this trial)

- Patients with significant respiratory compromise due to either abdominal tumor
limiting diaphragmatic excursion or pulmonary metastases should not receive bleomycin
and are ineligible for the trial

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs; a pregnancy test is required for female
patients of childbearing potential; (this criteria applies ONLY to patients who will
receive chemotherapy [SR1 and SR2 patients])

- Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to
patients who will receive chemotherapy [SR1 and SR2 patients])

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation; (this
criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2
patients])
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Anchorage, Alaska 99508
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Aurora, CO
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Brandon D. Bernard
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Aurora, IL
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Teresa A. York
Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Alan D. Friedman
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Baltimore, MD
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Nadine P. SantaCruz
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bangor, ME
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bardstown, KY
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Battle Creek, MI
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Bellflower, California 90706
Principal Investigator: Robert M. Cooper
Phone: 800-398-3996
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Bellflower, CA
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Bellingham, Washington 98225
Principal Investigator: Benjamin B. Bridges
Phone: 360-715-4133
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Bellingham, WA
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Belpre, OH
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Bend, Oregon 97701
Principal Investigator: Benjamin B. Bridges
Phone: 541-706-2909
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Bend, OR
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Berlin, Vermont 05602
Principal Investigator: Jessica L. Heath
Phone: 802-225-5400
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Berlin, VT
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, IL
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Benjamin B. Bridges
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Bonne Terre, MO
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: A. L. Frazier
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: A. L. Frazier
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bremerton, WA
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Brewer, Maine 04412
Principal Investigator: Nadine P. SantaCruz
Phone: 800-987-3005
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Brewer, ME
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Bridgeport, West Virginia 26330
Principal Investigator: Stephan R. Paul
Phone: 304-293-7374
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Bridgeport, WV
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Bryan, Texas 77802
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bryan, TX
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Burbank, California
Principal Investigator: Benjamin B. Bridges
Phone: 818-847-4793
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Burbank, CA
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Burien, Washington 98166
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Burien, WA
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Burlington, Vermont 05405
Principal Investigator: Jessica L. Heath
Phone: 802-656-4101
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Burlington, VT
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Canton, IL
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Cape Girardeau, MO
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Cape Girardeau, MO
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
Phone: 618-457-5200
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Carbondale, IL
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Carmel, Indiana 46032
Principal Investigator: Kamnesh R. Pradhan
Phone: 317-278-5632
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Carmel, IN
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Carson City, Nevada 89703
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Carson City, NV
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Carterville, Illinois 62918
Principal Investigator: Bryan A. Faller
Phone: 618-985-3333
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Carterville, IL
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Carthage, IL
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Centralia, Illinois 62801
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Centralia, IL
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Centralia, Washington 98531
Principal Investigator: Benjamin B. Bridges
Phone: 360-412-8958
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Centralia, WA
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jacqueline M. Kraveka
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 800-804-9376
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Charlotte, NC
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
Phone: 704-384-5369
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Charlotte, North Carolina 28207
Principal Investigator: Jessica A. Bell
Phone: 704-384-8920
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