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

Trial Status: Closed to Accrual

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.

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

Alabama

Birmingham
Children's Hospital of Alabama
Status: CLOSED_TO_ACCRUAL
Contact: Alyssa Terry Reddy
Phone: 205-638-9285

Arizona

Phoenix
Phoenix Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jessica Boklan
Phone: 602-546-0920

California

Downey
Kaiser Permanente Downey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert Michael Cooper
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Albert Kheradpour
Phone: 909-558-3375
Los Angeles
Children's Hospital Los Angeles
Status: CLOSED_TO_ACCRUAL
Contact: Leo Mascarenhas
Phone: 323-361-4110
Madera
Valley Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Vonda Lee Crouse
Phone: 866-353-5437
Oakland
Children's Hospital and Research Center at Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Carla Barbara Golden
Phone: 510-450-7600
Orange
Children's Hospital of Orange County
Status: CLOSED_TO_ACCRUAL
Contact: Violet Shen
Phone: 714-997-3000
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: CLOSED_TO_ACCRUAL
Contact: Neyssa Maria Marina
Phone: 650-498-7061
Sacramento
Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Yung Soon Yim
Phone: 415-209-2686
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: CLOSED_TO_ACCRUAL
Contact: William D. Roberts
Phone: 858-966-5934
San Francisco
UCSF Medical Center-Mission Bay
Status: CLOSED_TO_ACCRUAL
Contact: Michelle Lynn Hermiston
Phone: 877-827-3222

Colorado

Aurora
Children's Hospital Colorado
Status: CLOSED_TO_ACCRUAL
Contact: Timothy Price Garrington
Phone: 720-777-6672

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150

District of Columbia

Washington
Children's National Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Stuart Dome
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Amal Mousa Abu-Ghosh
Phone: 202-444-0381

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: CLOSED_TO_ACCRUAL
Contact: Emad K. Salman
Phone: 239-343-5333
Gainesville
University of Florida Health Science Center - Gainesville
Status: CLOSED_TO_ACCRUAL
Contact: William Birdsall Slayton
Phone: 352-273-8675
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Iftikhar Hanif
Phone: 954-265-2234
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Miami
Nicklaus Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Enrique Alberto Escalon
Phone: 888-624-2778
Orlando
AdventHealth Orlando
Status: CLOSED_TO_ACCRUAL
Contact: Fouad M. Hajjar
Phone: 407-303-2090
Arnold Palmer Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Nemours Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Pensacola
Nemours Children's Clinic - Pensacola
Status: CLOSED_TO_ACCRUAL
Contact: Ramamoorthy Nagasubramanian
Phone: 407-650-7150
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Alan Hale
Phone: 727-767-2423
West Palm Beach
Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Narayana Gowda

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: CLOSED_TO_ACCRUAL
Contact: Melinda Gordon Pauly
Savannah
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: J. Martin Johnston
Phone: 912-350-8568

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Eugenia Chang
Phone: 208-381-3376

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: CLOSED_TO_ACCRUAL
Contact: Joanna Lynn Weinstein
Phone: 773-880-4562
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Tara Olive Henderson
Phone: 773-834-7424
University of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Peoria
Saint Jude Midwest Affiliate
Status: CLOSED_TO_ACCRUAL
Contact: Pedro A. De Alarcon
Phone: 309-655-3258
Springfield
Southern Illinois University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: James Merrill Croop
Phone: 800-248-1199

Iowa

Des Moines
Blank Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-6729

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lars Martin Wagner
Phone: 859-257-3379

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: CLOSED_TO_ACCRUAL
Contact: Craig Lotterman
Phone: 888-562-4763

Maine

Scarborough
Maine Children's Cancer Program
Status: CLOSED_TO_ACCRUAL
Contact: Aaron Robert Weiss
Phone: 207-396-7565

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Allen R. Chen
Phone: 410-955-8804
Sinai Hospital of Baltimore
Status: CLOSED_TO_ACCRUAL
Contact: Jason M. Fixler
Phone: 410-601-6120

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Suzanne Shusterman
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard Jeffrey Weinstein
Phone: 877-726-5130
Springfield
Baystate Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Joanna G. Luty
Phone: 413-794-3565

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Rajen Mody
Phone: 800-865-1125
Detroit
Ascension Saint John Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Hadi Sawaf
Phone: 313-343-3166
Kalamazoo
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Emily G. Greengard
Phone: 612-624-2620

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Anderson (Andy) Burton Collier
Phone: 601-815-6700

Missouri

Kansas City
Children's Mercy Hospitals and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Keith Jason August
Phone: 816-234-3265
Saint Louis
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Robert J. Hayashi
Phone: 800-600-3606

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Nik Farahana Nik Abdul Rashid
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Nik Farahana Nik Abdul Rashid
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Sara Chaffee
Phone: 800-639-6918

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Burton Eliot Appel
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Richard A. Drachtman
Phone: 732-235-8675
Newark
Newark Beth Israel Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Peri Kamalakar
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mary Ann Bonilla
Phone: 973-754-2909

New York

Albany
Albany Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: CLOSED_TO_ACCRUAL
Contact: Jonathan Benjamin Gill
Phone: 718-904-2730
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Meghan A. Higman
Phone: 877-275-7724
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Alice Lee
Phone: 212-305-8615
NYP / Weill Cornell Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Lisa Giulino Roth
Phone: 212-746-1848
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert Ingalls Parker
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: CLOSED_TO_ACCRUAL
Contact: Melanie A. Comito
Phone: 315-464-5476
Valhalla
New York Medical College
Status: CLOSED_TO_ACCRUAL
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Joel A. Kaplan
Phone: 704-355-2884
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Samuel Odame Anim
Phone: 701-234-6161

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: CLOSED_TO_ACCRUAL
Contact: Steven J. Kuerbitz
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Maureen Megan O'Brien
Phone: 513-636-2799
Cleveland
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mark Anthony Ranalli
Phone: 614-722-2708
Dayton
Dayton Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ayman Aly El-Sheikh
Phone: 800-228-4055

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Janice Faye Olson
Phone: 503-413-2560
Oregon Health and Science University
Status: CLOSED_TO_ACCRUAL
Contact: Susan Joy Lindemulder
Phone: 503-494-1080

Pennsylvania

Hershey
Penn State Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Lisa MacNabb McGregor
Phone: 717-531-6012
Philadelphia
Children's Hospital of Philadelphia
Status: CLOSED_TO_ACCRUAL
Contact: Leslie S. Kersun
Phone: 215-590-2810
Saint Christopher's Hospital for Children
Status: CLOSED_TO_ACCRUAL
Contact: Akash Nahar
Phone: 215-427-8991
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: CLOSED_TO_ACCRUAL
Contact: Jean M. Tersak
Phone: 412-692-5573

South Carolina

Greenville
BI-LO Charities Children's Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nichole Leigh Bryant
Phone: 864-241-6251

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Ray C. Pais
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wayne Lee Furman
Phone: 866-278-5833
Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Debra L Friedman
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: CLOSED_TO_ACCRUAL
Contact: Amy Fowler Tellinghuisen
Phone: 214-648-7097
Corpus Christi
Driscoll Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Nkechi Ifeoma Mba
Phone: 361-694-5311
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Martha Marie Pacheco
Phone: 214-648-7097
Fort Worth
Cook Children's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth Matthew Heym
Phone: 682-885-2103
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Terzah M. Horton
Phone: 713-798-1354
San Antonio
Children's Hospital of San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Terzah M. Horton
Phone: 713-798-1354
Methodist Children's Hospital of South Texas
Status: CLOSED_TO_ACCRUAL
Contact: Gerardo Quezada
Phone: 210-575-7000
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800

Utah

Salt Lake City
Primary Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Phillip Evan Barnette
Phone: 801-585-5270

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: CLOSED_TO_ACCRUAL
Contact: Eric Jeffrey Lowe
Phone: 757-668-7243
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Gita Vasers Massey
Phone: 804-628-1939

Washington

Seattle
Seattle Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Douglas S. Hawkins
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Judy L. Felgenhauer
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Melissa Anne Forouhar
Phone: 253-968-0129

West Virginia

Morgantown
West Virginia University Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Stephan R. Paul
Phone: 304-293-7374

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth Brian De Santes
Phone: 715-422-7718
Milwaukee
Children's Hospital of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Michael Edward Kelly
Phone: 414-805-4380

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Carol A. Portwine
Phone: 905-521-2100ext74595
Kingston
Kingston Health Sciences Centre
Status: CLOSED_TO_ACCRUAL
Contact: Mariana Pradier Silva
Phone: 613-544-2630
London
Children's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shayna M. Zelcer
Phone: 519-685-8306
Toronto
Hospital for Sick Children
Status: CLOSED_TO_ACCRUAL
Contact: Sarah Weeks Alexander
Phone: 416-813-7654ext2027

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: CLOSED_TO_ACCRUAL
Contact: Yvan Samson
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: CLOSED_TO_ACCRUAL
Contact: Sharon Barbara Abish
Phone: 514-412-4445
Quebec
Centre Hospitalier Universitaire de Quebec
Status: CLOSED_TO_ACCRUAL
Contact: Bruno Michon

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of brentuximab vedotin in combination with gemcitabine 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 15 more 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.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Childrens Oncology Group

Principal Investigator
Peter David Cole

  • Primary ID AHOD1221
  • Secondary IDs NCI-2013-00107, COG-AHOD1221
  • Clinicaltrials.gov ID NCT01780662