Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients with Relapsed or Refractory Hodgkin Lymphoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive13 months to 30 yearsAHOD1221
NCI-2013-00107, COG-AHOD1221, NCT01780662

Trial Description

Summary

This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with gemcitabine hydrochloride and to see how well they work in treating younger patients with Hodgkin lymphoma that has returned or does not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of brentuximab vedotin in combination with gemcitabine (gemcitabine hydrochloride) administered every three weeks to children with relapsed or primary refractory Hodgkin lymphoma (HL).

II. To define and describe the toxicities of brentuximab vedotin in combination with gemcitabine administered on this schedule.

III. To determine the complete response (CR) rate after treatment with four cycles of gemcitabine with brentuximab vedotin among patients with relapsed or refractory HL.

SECONDARY OBJECTIVES:

I. To preliminarily define the antitumor activity of brentuximab vedotin in combination with gemcitabine within the confines of a Phase 1 study.

II. To describe the overall response rate (ORR) after 4 cycles of therapy among patients with relapsed or refractory HL.

III. To describe the proportion of patients with HL able to mobilize an adequate yield of cluster of differentiation (CD) 34+ stem cells after gemcitabine with brentuximab vedotin.

IV. To describe the relationship between disease response among patients with HL and changes in thymus and activation-regulated chemokine (TARC) during treatment, and to determine if specific micro ribonucleic acid (miRNA) profiles correlate with response to treatment.

V. To describe the frequency of the Fc gamma receptor IIIa (FcγRIIIa)-158 valine (V)/phenylalanine (F) polymorphism among patients who experience pulmonary toxicity on this protocol.

OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study. (Phase I completed as of amendment 4)

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

Eligibility Criteria

Inclusion Criteria:

Patients must have had histologic verification of the malignancy at original diagnosis; patients must have histologic verification of recurrent Hodgkin disease at the time of relapse; no additional biopsy is required for patients with primary refractory disease (i.e. no prior CR)

PARTS A AND B: Patients with Hodgkin lymphoma (HL) are eligible for both the phase 1 and 2 portions, if they are in one of the following categories:

Primary refractory disease (i.e. no prior CR)

Very early relapse (< 6 months from the end of initial therapy, including chemotherapy ± radiation)

Advanced stage (III or IV) at diagnosis who relapse less than one year from the end of initial therapy

Note that patients with low-stage disease (IA or IIA) at initial diagnosis, who were treated with radiation alone or fewer than four cycles of chemotherapy will NOT be eligible

Patients must have measurable disease, documented by clinical and radiographic criteria

Patients must have a life expectancy of >= 8 weeks (>= 56 days)

Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy

At least 14 days after the last dose of myelosuppressive chemotherapy (28 days if prior nitrosourea); Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy

At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair

At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair

At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines

At least 3 half-lives of the antibody after the last dose of a monoclonal antibody

At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation

Patients with prior autologous or allogeneic stem cell transplant (SCT) are excluded from this study

At least 28 days must have elapsed since the most recent dose of bleomycin, to allow adequate time to detect evidence of bleomycin-related pulmonary toxicity

PART A: FOR PATIENTS WITH KNOWN BONE MARROW INVOLVEMENT (Completed as of Amendment 4)

Peripheral absolute neutrophil count (ANC) >= 1000/uL

Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)

PART B: FOR PATIENTS WITHOUT KNOWN BONE MARROW INVOLVEMENT

Peripheral absolute neutrophil count (ANC) >= 750/uL

Platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)

Patients with lymphoma metastatic to bone marrow who have granulocytopenia, anemia, and/or thrombocytopenia will be eligible for study but not evaluable for hematologic toxicity (in Part A, there will be a maximum of one per cohort); such patients must meet the blood counts as in Part A (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled in Part A must be evaluable for hematologic toxicity

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

A serum creatinine based on age/gender as follows:

=< 0.6 mg/dL (for 1 to < 2 years of age)

=< 0.8 mg/dL (for 2 to < 6 years of age)

=< 1.0 mg/dL (for 6 to < 10 years of age)

=< 1.2 mg/dL (for 10 to < 13 years of age)

=< 1.4 mg/dL (for females >= 13 years of age)

=< 1.5 mg/dL (for males 13 to < 16 years of age)

=< 1.7 mg/dL (for males >= 16 years of age)

Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age

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

Serum albumin >= 2 g/dL

No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air

Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and forced vital capacity all > 50% predicted value; Note: pulmonary function testing is not required for children < 8 years old, or for any child who is developmentally unable to comply with pulmonary function testing

Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled

Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be < grade 2

Exclusion Criteria:

Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during protocol therapy and for at least 30 days after the last dose of brentuximab vedotin; abstinence is an acceptable method of birth control

Concomitant medications

Patients receiving stable or decreasing corticosteroids are not eligible for other concurrent conditions (e.g. asthma, autoimmune diseases, rash, documented adrenal insufficiency) are eligible for this study

Patients who are currently receiving another investigational drug are not eligible

Patients who are currently receiving other anti-cancer agents are not eligible

Patients who have an uncontrolled infection are not eligible

Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible

Patients known to be positive for human immunodeficiency virus (HIV) are not eligible

Prior therapy

Patients with prior exposure to brentuximab vedotin are not eligible; NOTE: prior exposure to gemcitabine is NOT an exclusion criterion

Patients who have undergone prior autologous or allogeneic SCT are not eligible

Patients with HL who were stage IA or IIA at initial diagnosis and treated with either radiation alone or < 4 cycles of chemotherapy are not eligible

Patients who have received a prior solid organ transplantation are not eligible

Patients with known hypersensitivity to Escherichia coli (E.coli)-derived proteins, filgrastim, or any component of filgrastim are not eligible

Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

All patients and/or their parents or legal guardians must sign a written informed consent

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Peter David Cole, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 205-975-1941
Email: areddy@peds.uab.edu

Alyssa Terry Reddy
Principal Investigator

Arizona
Phoenix

Phoenix Childrens Hospital

Jessica Boklan
Ph: 602-933-0276
Email: jboklan@phoenixchildrens.com

Jessica Boklan
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 323-783-3656
Email: robert.m.cooper@kp.org

Robert Michael Cooper
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-0702
Email: akheradp@llu.edu

Albert Kheradpour
Principal Investigator

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-8174
Email: lmascarenhas@chla.usc.edu

Leo Mascarenhas
Principal Investigator

Madera

Children's Hospital Central California

Vonda Lee Crouse
Ph: 559-353-5490
Email: vcrouse@valleychildrens.org

Vonda Lee Crouse
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Carla Barbara Golden
Ph: 510-601-3916
Email: cgolden@mail.cho.org

Carla Barbara Golden
Principal Investigator

Orange

Children's Hospital of Orange County

Violet Shen
Ph: 714-509-8699
Email: vshen@choc.org

Violet Shen
Principal Investigator

Palo Alto

Lucile Packard Children's Hospital Stanford University

Neyssa Maria Marina
Ph: 650-723-5231
Email: clinicaltrials@med.stanford.edu

Neyssa Maria Marina
Principal Investigator

Sacramento

Sutter General Hospital

Yung Soon Yim
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Yung Soon Yim
Principal Investigator

University of California Davis Comprehensive Cancer Center

Marcio Henrique Malogolowkin
Ph: 916-451-3014
Email: mmalogolowkin@ucdavis.edu

Marcio Henrique Malogolowkin
Principal Investigator

San Diego

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-8035
Email: wroberts@rchsd.org

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Michelle Lynn Hermiston
Ph: 877-827-3222
Email: hermistonm@peds.ucsf.edu

Michelle Lynn Hermiston
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Timothy Price Garrington
Ph: 720-777-6672
Email: timothy.garrington@childrenscolorado.org

Timothy Price Garrington
Principal Investigator

Connecticut
New Haven

Yale University

Nina Singh Kadan-Lottick
Ph: 203-737-2228
Email: nina.kadan-lottick@yale.edu

Nina Singh Kadan-Lottick
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Ramamoorthy Nagasubramanian
Ph: 407-650-7233
Email: rnagasub@nemours.org

Ramamoorthy Nagasubramanian
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-476-5685
Email: jdome@childrensnational.org

Jeffrey Stuart Dome
Principal Investigator

MedStar Georgetown University Hospital

Aziza Tahir Shad
Ph: 202-444-8817
Email: shada@georgetown.edu

Aziza Tahir Shad
Principal Investigator

Florida
Hollywood

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-985-2288
Email: ihanif@mhs.net

Iftikhar Hanif
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Ramamoorthy Nagasubramanian
Ph: 407-650-7233
Email: rnagasub@nemours.org

Ramamoorthy Nagasubramanian
Principal Investigator

Orlando

Arnold Palmer Hospital for Children

Vincent Ferdinando Giusti
Ph: 321-841-7743
Email: vincent.giusti@orlandohealth.com

Vincent Ferdinando Giusti
Principal Investigator

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-2085
Email: fouad.hajjar.md@flhosp.org

Fouad M. Hajjar
Principal Investigator

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7233
Email: rnagasub@nemours.org

Ramamoorthy Nagasubramanian
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Ramamoorthy Nagasubramanian
Ph: 407-650-7233
Email: rnagasub@nemours.org

Ramamoorthy Nagasubramanian
Principal Investigator

Saint Petersburg

All Children's Hospital

Gregory Alan Hale
Ph: 727-767-4379
Email: HamblinF@allkids.org

Gregory Alan Hale
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

Melinda Gordon Pauly
Ph: 888-785-1112
Email: melinda.pauly@choa.org

Melinda Gordon Pauly
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Joanna Lynn Weinstein
Ph: 312-227-9756
Email: ksparks@luriechildrens.org

Joanna Lynn Weinstein
Principal Investigator

University of Chicago Comprehensive Cancer Center

Tara Olive Henderson
Ph: 773-702-9881
Email: thenderson@peds.bsd.uchicago.edu

Tara Olive Henderson
Principal Investigator

University of Illinois

Mary Lou Schmidt
Ph: 312-413-9484
Email: mls3@uic.edu

Mary Lou Schmidt
Principal Investigator

Peoria

Saint Jude Midwest Affiliate

Karen Sofia Fernandez
Ph: 309-624-9848
Email: kfernand@uic.edu

Karen Sofia Fernandez
Principal Investigator

Springfield

Southern Illinois University School of Medicine

Gregory P. Brandt
Ph: 217-545-4788
Email: gbrandt@siumed.edu

Gregory P. Brandt
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

James Merrill Croop
Ph: 317-948-0616
Email: jcroop@iupui.edu

James Merrill Croop
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-8988
Email: wendy.woods-swafford@unitypoint.org

Wendy Leigh Woods-Swafford
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-6048
Email: lars.wagner@uky.edu

Lars Martin Wagner
Principal Investigator

Louisiana
New Orleans

Ochsner Medical Center Jefferson

Craig Lotterman
Ph: 504-842-5250
Email: clotterman@ochsner.org

Craig Lotterman
Principal Investigator

Maine
Scarborough

Maine Children's Cancer Program

Aaron Robert Weiss
Ph: 207-396-7577
Email: weissa2@mmc.org

Aaron Robert Weiss
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Allen R. Chen
Ph: 410-502-6902
Email: jhcccro@jhmi.edu

Allen R. Chen
Principal Investigator

Sinai Hospital of Baltimore

Joseph M. Wiley
Ph: 410-601-8766
Email: pridgely@lifebridgehealth.org

Joseph M. Wiley
Principal Investigator

Massachusetts
Boston

Dana-Farber/Harvard Cancer Center

Suzanne Shusterman
Ph: 617-632-5710
Email: suzanne_shusterman@dfci.harvard.edu

Suzanne Shusterman
Principal Investigator

Massachusetts General Hospital Cancer Center

Howard Jeffrey Weinstein
Ph: 617-724-8526
Email: hweinstein@partners.org

Howard Jeffrey Weinstein
Principal Investigator

Springfield

Baystate Medical Center

Joanna G. Luty
Ph: 413-794-3307
Email: tamara.wrenn@baystatehealth.org

Joanna G. Luty
Principal Investigator

Michigan
Ann Arbor

C S Mott Children's Hospital

Rajen Mody
Ph: 800-865-1125
Email: rmody@umich.edu

Rajen Mody
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

Hadi Sawaf
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Katharina Elisabeth Elliott
Ph: 269-341-8580
Email: elliottk@bronsonhg.org

Katharina Elisabeth Elliott
Principal Investigator

Minnesota
Minneapolis

University of Minnesota/Masonic Cancer Center

Emily G. Greengard
Ph: 612-626-2815
Email: emilyg@umn.edu

Emily G. Greengard
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Anderson (Andy) Burton Collier
Ph: 601-984-5279
Email: acollier@umc.edu

Anderson (Andy) Burton Collier
Principal Investigator

Missouri
Kansas City

The Childrens Mercy Hospital

Maxine Lorraine Hetherington
Ph: 816-302-9894
Email: mhetherington@cmh.edu

Maxine Lorraine Hetherington
Principal Investigator

Saint Louis

Washington University School of Medicine

Robert J. Hayashi
Ph: 314-454-2780
Email: info@siteman.wustl.edu

Robert J. Hayashi
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Nik Farahana Nik Abdul Rashid
Ph: 702-732-1080
Email: nrashid@cure4thekids.org

Nik Farahana Nik Abdul Rashid
Principal Investigator

Sunrise Hospital and Medical Center

Nik Farahana Nik Abdul Rashid
Ph: 702-732-1080
Email: nrashid@cure4thekids.org

Nik Farahana Nik Abdul Rashid
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Sara Chaffee
Ph: 603-650-0591
Email: cancer.research.nurse@dartmouth.edu

Sara Chaffee
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Burton Eliot Appel
Ph: 201-487-7340
Email: bappel@hackensackumc.org

Burton Eliot Appel
Principal Investigator

New Brunswick

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8234
Email: drachtri@cinj.rutgers.edu

Richard A. Drachtman
Principal Investigator

Paterson

Saint Joseph's Regional Medical Center

Mary Ann Bonilla
Ph: 973-754-3331
Email: bonillam@sjhmc.org

Mary Ann Bonilla
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-5889
Email: kanwarv@mail.amc.edu

Vikramjit Singh Kanwar
Principal Investigator

Bronx

Montefiore Medical Center - Moses Campus

Peter David Cole
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Peter David Cole
Principal Investigator

New York

Columbia University/Herbert Irving Cancer Center

Alice Lee
Ph: 212-305-5848
Email: al2041@cumc.columbia.edu

Alice Lee
Principal Investigator

Weill Medical College of Cornell University

Lisa Giulino Roth
Ph: 212-746-8609
Email: lgr2002@med.cornell.edu

Lisa Giulino Roth
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-273-1039
Email: jeffrey_andolina@urmc.rochester.edu

Jeffrey Robert Andolina
Principal Investigator

Stony Brook

Stony Brook University Medical Center

Robert Ingalls Parker
Ph: 631-444-2785
Email: robert.parker@stonybrookmedicine.edu

Robert Ingalls Parker
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Karol Hicks Kerr
Ph: 315-464-7238
Email: kerrk@upstate.edu

Karol Hicks Kerr
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-2143
Email: jessica_hochberg@nymc.edu

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Charlotte

Carolinas Medical Center/Levine Cancer Institute

Joel A. Kaplan
Ph: 704-381-9901
Email: joel.kaplan@carolinashealthcare.org

Joel A. Kaplan
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Thomas Bennett Russell
Ph: 336-716-3010
Email: trussell@wakehealth.edu

Thomas Bennett Russell
Principal Investigator

North Dakota
Fargo

Sanford Medical Center-Fargo

Samuel Odame Anim
Ph: 701-234-7577
Email: samuel.anim@sanfordhealth.org

Samuel Odame Anim
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193
Email: skuerbitz@chmca.org

Steven J. Kuerbitz
Principal Investigator

Cincinnati

Cincinnati Children's Hospital Medical Center

Maureen Megan O'Brien
Ph: 513-636-3549
Email: maureen.obrien@cchmc.org

Maureen Megan O'Brien
Principal Investigator

Cleveland

Cleveland Clinic Foundation

Aron Flagg
Ph: 216-444-3577
Email: flagga@ccf.org

Aron Flagg
Principal Investigator

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5431
Email: yousif.matloub@uhhospitals.org

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-3699
Email: mark.ranalli@nationwidechildrens.org

Mark Anthony Ranalli
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Rene Yvonne McNall-Knapp
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Rene Yvonne McNall-Knapp
Principal Investigator

Oregon
Portland

Legacy Emanuel Children's Hospital

Janice Faye Olson
Ph: 503-276-9351
Email: jfolson@lhs.org

Janice Faye Olson
Principal Investigator

Oregon Health and Science University

Susan Joy Lindemulder
Ph: 503-494-0714
Email: trials@ohsu.edu

Susan Joy Lindemulder
Principal Investigator

Pennsylvania
Hershey

Penn State Hershey Children's Hospital

Lisa MacNabb McGregor
Ph: 717-531-4787
Email: lmcgregor@hmc.psu.edu

Lisa MacNabb McGregor
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

Leslie S. Kersun
Ph: 215-590-7544
Email: segall@email.chop.edu

Leslie S. Kersun
Principal Investigator

Saint Christopher's Hospital for Children

Akash Nahar
Ph: 215-427-6684
Email: akash.nahar@tenethealth.com

Akash Nahar
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Jean M. Tersak
Ph: 412-692-7693
Email: jean.tersak@chp.edu

Jean M. Tersak
Principal Investigator

South Carolina
Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-455-5164
Email: nbryant@ghs.org

Nichole Leigh Bryant
Principal Investigator

South Dakota
Sioux Falls

Sanford USD Medical Center - Sioux Falls

Kayelyn Jean Wagner
Ph: 605-328-1367

Kayelyn Jean Wagner
Principal Investigator

Tennessee
Knoxville

East Tennessee Childrens Hospital

Ray C. Pais
Ph: 865-541-8553
Email: raycpais@knology.net

Ray C. Pais
Principal Investigator

Memphis

St. Jude Children's Research Hospital

Wayne Lee Furman
Ph: 901-521-9005
Email: info@stjude.org

Wayne Lee Furman
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Debra L. Friedman
Ph: 615-936-1767
Email: debra.l.friedman@vanderbilt.edu

Debra L. Friedman
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Amy Catherine Fowler
Ph: 512-628-1901
Email: acFowler@seton.org

Amy Catherine Fowler
Principal Investigator

Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Martha Marie Stegner
Ph: 214-648-3122
Email: martha.stegner@childrens.com

Martha Marie Stegner
Principal Investigator

Fort Worth

Cook Children's Medical Center

Kenneth Matthew Heym
Ph: 682-885-1712
Email: kenneth.heym@cookchildrens.org

Kenneth Matthew Heym
Principal Investigator

Houston

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Terzah M. Horton
Ph: 832-825-1449
Email: burton@bcm.edu

Terzah M. Horton
Principal Investigator

San Antonio

Children's Hospital of San Antonio

Timothy C. Griffin
Ph: 800-248-1199

Timothy C. Griffin
Principal Investigator

Methodist Children's Hospital of South Texas

Gerardo Quezada
Ph: 210-575-6254
Email: Gerardo.Quezada@mhshealth.com

Gerardo Quezada
Principal Investigator

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
Principal Investigator

Utah
Salt Lake City

Primary Children's Hospital

Phillip Evan Barnette
Ph: 801-662-4707
Email: phillip.barnette@imail.org

Phillip Evan Barnette
Principal Investigator

Virginia
Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7811
Email: eric.lowe@chkd.org

Eric Jeffrey Lowe
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Gita Vasers Massey
Ph: 804-828-6455
Email: gmassey2@mcvh-vcu.edu

Gita Vasers Massey
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 206-987-3946
Email: doug.hawkins@seattlechildrens.org

Douglas S. Hawkins
Principal Investigator

Spokane

Providence Sacred Heart Medical Center and Children's Hospital

Judy L. Felgenhauer
Ph: 509-474-6222
Email: HopeBeginsHere@providence.org

Judy L. Felgenhauer
Principal Investigator

Tacoma

Madigan Army Medical Center

Melissa Anne Forouhar
Ph: 253-968-1900
Email: mamcdci@amedd.army.mil

Melissa Anne Forouhar
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Stephan R. Paul
Ph: 304-293-1216
Email: sfilburn@hsc.wvu.edu

Stephan R. Paul
Principal Investigator

Wisconsin
Madison

University of Wisconsin Hospital and Clinics

Kenneth Brian De Santes
Ph: 608-265-9721
Email: kbdesantes@pediatrics.wisc.edu

Kenneth Brian De Santes
Principal Investigator

Milwaukee

Midwest Children's Cancer Center

Michael Edward Kelly
Ph: 414-955-6543
Email: mekelly@mcw.edu

Michael Edward Kelly
Principal Investigator

Canada

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-1703
Email: portwc@mcmaster.ca

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630
Email: mps@queensu.ca

Mariana Pradier Silva
Principal Investigator

Toronto

Hospital for Sick Children

Sarah Weeks Alexander
Ph: 416-813-5327
Email: jason.mcguire@sickkids.ca

Sarah Weeks Alexander
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931
Email: yvan.samson@umontreal.ca

Yvan Samson
Principal Investigator

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 888-823-5923
Email: ctsucontact@westat.com

Bruno Michon
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01780662

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.