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Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

This study is currently recruiting participants.
Verified November 2017 by National Cancer Institute (NCI)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02484443
First Posted: June 29, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.

Condition Intervention Phase
Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma Recurrent Osteosarcoma Biological: Dinutuximab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Biological: Sargramostim Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Human-Mouse Chimeric Anti-disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038) in Combination With Sargramostim (GM-CSF) in Patients With Recurrent Osteosarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease control [ Time Frame: During the first 12 months ]
    The probability of remaining event-free as a function of time since enrollment will be estimated by the method of Kaplan and Meier. The complementary log-log transformation of the Kaplan-Meier estimate of the 12 month disease control probability will be used to construct confidence intervals of that probability. Only patients who can be confirmed to be free of detectable disease 12 months after enrollment, without intervening disease progression, will be considered to have experienced 12 month disease control.


Secondary Outcome Measures:
  • Incidence of unacceptable toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 4 years ]
    A Bayesian rule will be used to monitor for excessive toxicity. Descriptive analyses of this safety information will be performed and will include the incidence of adverse events, severe adverse events, serious adverse events, and fatal adverse events. Type, frequency, and severity of laboratory abnormalities will also be analyzed.

  • Pharmacokinetics of dinutuximab [ Time Frame: Baseline, 4 hours, and immediately before end of dinutuximab infusion on day 4, 4 hours before, immediately before, 4-8 hours, and 4-10 days following dinutuximab infusion on day 5 of course 1, and then prior to the start of course 2 ]
    The average and standard deviation of estimates will be reported.


Other Outcome Measures:
  • Banking of tumor samples (optional) [ Time Frame: During first 12 months from enrollment ]
    Individual statistical plans will be developed for future studies answering a specific question using these banked tumor specimens.

  • Change in circulating ligand B7-H6 levels [ Time Frame: Baseline up to 4 years ]
    Additionally, serum for the evaluation of ligand levels at relapse will be requested. The change will be estimated by the average intra-patient change and the variance will be estimated by the variance of the intra-patient differences.

  • Circulating tumor deoxyribonucleic acid detection [ Time Frame: Up to 4 years ]
    Statistical considerations for specific future studies will be provided.

  • KIR, NKp30, and FcgammaR genotype analyses [ Time Frame: Baseline ]
    The outcome measure will be DC success (yes versus no). Logistic regression using the categorical FcgammaR result will be fitted to the data. The fitted coefficients from the logistic regression, and the p-value for the test of the hypothesis of no relationship between FcgammaR result and probability of DC success will be used to characterize this exploratory analysis. Logistic regression using the categorical KIR/KIR ligand mismatch (present v. absent) will be fitted to the data.

  • Profile of HACA during immunotherapy [ Time Frame: Up to 30 days post-treatment ]
    At each time point, the optical density of the enzyme-linked immunosorbent assay (ELISA) bridging assay will be calculated. The number of patients who are HACA positive divided by the number of patients with a successful HACA assay at each time point will be used to quantify the fraction of patients displaying HACA activity. Will also graph the average optical density of the ELISA assay over all patients at each time point.

  • Tumor GD2 expression [ Time Frame: Up to 4 weeks post-treatment ]
    The relationship between probability of disease control (DC) and tumor GD2 expression will be assessed. The outcome measure will be DC success (yes versus no). Logistic regression using the categorical immunohistochemistry (IHC) result will be fitted to the data. The fitted coefficients from the logistic regression, and the p-value for the test of the hypothesis of no relationship between IHC result and probability of DC success will be used to characterize this exploratory analysis. Trend will also be assessed using the actual IHC numerical value.


Estimated Enrollment: 44
Actual Study Start Date: November 30, 2015
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (sargramostim and dinutuximab)
Patients receive sargramostim SC QD on days 1-14 and dinutuximab IV over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]) as compared to historical Children's Oncology Group (COG) experience.

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetics of ch14.18 (dinutuximab) in patients with recurrent osteosarcoma.

II. To determine the occurrence of unacceptable toxicity (UT) in patients with recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim.

III. To assess the relationship between probability of disease control and tumor ganglioside GD2 (GD2) expression.

TERTIARY OBJECTIVES:

I. To assess the relationship between probability of disease control and tumor GD2 expression.

II. To assess KIR and Fcgamma receptor (FcgammaR) genotypes, NKp30 isoforms and its circulating ligand, B7-H6, and their relationships to the probability of disease control.

III. To attempt banking of tumor samples for future research studies from patients enrolled on study who undergo biopsy or resection of suspected metastatic disease recurrence while on protocol therapy or during the evaluation period.

IV. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.

V. To bank serial plasma samples for future studies of circulating tumor deoxyribonucleic acid (ctDNA) detection as a marker of disease progression and response.

OUTLINE:

Patients receive sargramostim subcutaneously (SC) once daily (QD) on days 1-14 and dinutuximab intravenously (IV) over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 8 and 12 months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic diagnosis of osteosarcoma at original diagnosis
  • Patients must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:

    • Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment**
    • Pathologic confirmation of metastases from at least one of the resected sites

      • For patients with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery
    • Note: If surgery related changes such as atelectasis are seen on the post-operative computed tomography (CT) scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected; patients with positive microscopic margins will be eligible to enroll
  • Patient must have adequate tumor specimen available for submission
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    • Myelosuppressive anti-cancer therapy: must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea)
    • Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent
    • Radiation therapy (RT): >= 2 weeks for local palliative radiation therapy (RT) (small port); >= 6 weeks must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
    • Surgery: >= 2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies
  • Patient must not have received pegfilgrastim within 14 days of enrollment
  • Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment
  • Patient must not have received immune suppressants: corticosteroids (for other than allergic reactions and anaphylaxis), cyclosporine or tacrolimus within 7 days of enrollment

    • Note: the use of topical and/or inhalational steroids is allowed
  • Total absolute phagocyte count (APC = [%neutrophils + %monocytes) x white blood cells [WBC]) is at least 1000/uL
  • Platelet count >= 50,000/uL
  • 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:

    • 1 month to < 6 months: 0.4 (male) 0.4 (female)
    • 6 months to < 1 year: 0.5 (male), 0.5 (female)
    • 1 to < 2 years: 0.6 (male), 0.6 (female)
    • 2 to < 6 years: 0.8 (male), 0.8 (female)
    • 6 to < 10 years: 1 (male), 1 (female)
    • 10 to < 13 years: 1.2 (male), 1.2 (female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • >= 16 years: 1.7 (male), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL
  • Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< 470 milliseconds (ms)
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
  • No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry > 94%
  • Patient has no known history of seizure disorder
  • Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2

Exclusion Criteria:

  • Patients with distant bone metastases at original diagnosis or relapse (patients with only skip lesions will be eligible)
  • Patients with concurrent local and pulmonary recurrence at the time of enrollment; note: patients who had local recurrence previously that has been treated and now present with an isolated pulmonary recurrence and meet the surgical resection criteria stated above will be eligible
  • Patients with primary refractory disease with progression of the primary tumor on initial therapy
  • Patients with CNS disease or other sites of extra-pulmonary metastases at the time of most recent episode of disease recurrence preceding enrollment
  • Patients with a prior hypersensitivity reaction to sargramostim
  • Patients who have received prior anti-GD2 therapy, including chimeric antigen receptor (CAR) T cells directed against GD2 antigen
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation; patients should maintain adequate contraception for a minimum of 2 months after the last dose of ch14.18 (dinutuximab)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484443


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alyssa T. Reddy         
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-686-8274      
Principal Investigator: David L. Becton         
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour    909-558-3375      
Principal Investigator: Albert Kheradpour         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Elyssa M. Rubin       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sheri L. Spunt    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sheri L. Spunt         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Marcio H. Malogolowkin    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Robert E. Goldsby    877-827-3222      
Principal Investigator: Robert E. Goldsby         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Timothy P. Garrington       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy P. Garrington         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    800-579-7822      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
United States, Florida
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: William B. Slayton    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: William B. Slayton         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Jonathan L. Metts       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jonathan L. Metts         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Mark J. Mogul       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark J. Mogul         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda       helpdesk@childrensoncologygroup.org   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: William T. Cash       helpdesk@childrensoncologygroup.org   
Principal Investigator: William T. Cash         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: David O. Walterhouse       helpdesk@childrensoncologygroup.org   
Principal Investigator: David O. Walterhouse         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-7424      
Principal Investigator: Susan L. Cohn         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Pedro A. De Alarcon    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kamnesh R. Pradhan    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-3305    rbehrens@cancercenterofiowa.com   
Principal Investigator: Wendy L. Woods-Swafford         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ashok B. Raj    502-562-3429      
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    504-842-3708      
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Nadine P. SantaCruz    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Jason M. Fixler    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Brian H. Ladle    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Brian H. Ladle         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katherine A. Janeway    877-442-3324      
Principal Investigator: Katherine A. Janeway         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Katherine A. Janeway    877-442-3324      
Principal Investigator: Katherine A. Janeway         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Rama Jasty       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rama Jasty         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Adonis N. Lorenzana    313-343-3166      
Principal Investigator: Adonis N. Lorenzana         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Kathleen J. Yost    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Laura K. Gowans    248-551-7695      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily G. Greengard       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carola A. Arndt    855-776-0015      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Anderson (Andy) B. Collier    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
The Childrens Mercy Hospital Suspended
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: William S. Ferguson       helpdesk@childrensoncologygroup.org   
Principal Investigator: William S. Ferguson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Frederick S. Huang    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Frederick S. Huang         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michael B. Harris    201-996-2879      
Principal Investigator: Michael B. Harris         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Vikramjit S. Kanwar    518-262-3368      
Principal Investigator: Vikramjit S. Kanwar         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Lisa Figueiredo    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Lisa Figueiredo         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Sharon L. Gardner    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Philip M. Monteleone    315-464-5476      
Principal Investigator: Philip M. Monteleone         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica C. Hochberg    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
United States, North Dakota
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Samuel O. Anim    800-437-4010      
Principal Investigator: Samuel O. Anim         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Joseph G. Pressey       helpdesk@childrensoncologygroup.org   
Principal Investigator: Joseph G. Pressey         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jamie L. Dargart    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Suman Malempati    503-494-1080    trials@ohsu.edu   
Principal Investigator: Suman Malempati         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Richard B. Womer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Richard B. Womer         
Childrens Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Pooja Hingorani    602-933-0920    phingorani@phoenixchildrens.com   
Principal Investigator: Pooja Hingorani         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jean M. Tersak       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jean M. Tersak         
United States, South Carolina
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Michael W. Bishop       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael W. Bishop         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Amy C. Fowler       helpdesk@childrensoncologygroup.org   
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Nkechi I. Mba       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Stanton C. Goldman    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Theodore W. Laetsch    214-648-7097      
Principal Investigator: Theodore W. Laetsch         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Lauren J. Akers       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lauren J. Akers         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Nino C. Rainusso Guainazzo    713-798-1354    burton@bcm.edu   
Principal Investigator: Nino C. Rainusso Guainazzo         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Kishor M. Bhende    806-775-8590      
Principal Investigator: Kishor M. Bhende         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    800-248-1199      
Principal Investigator: Timothy C. Griffin         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Anne-Marie R. Langevin    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette       helpdesk@childrensoncologygroup.org   
Principal Investigator: Phillip E. Barnette         
United States, Virginia
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins       helpdesk@childrensoncologygroup.org   
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    301-319-2100      
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Stephan R. Paul    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Paul D. Harker-Murray    214-648-7097      
Principal Investigator: Paul D. Harker-Murray         
Australia, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
Australia, Queensland
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Geoffrey B. McCowage    (02) 9845 8183      
Principal Investigator: Geoffrey B. McCowage         
Australia, South Australia
Women's and Children's Hospital-Adelaide Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby       helpdesk@childrensoncologygroup.org   
Principal Investigator: Maria L. Kirby         
Australia, Victoria
Monash Medical Center-Clayton Campus Suspended
Clayton, Victoria, Australia, 3168
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Jordan R. Hansford       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jordan R. Hansford         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Marianne B. Phillips    (08) 9340 8222    catherine.cole@health.wa.gov.au   
Principal Investigator: Marianne B. Phillips         
Canada, Alberta
Alberta Children's Hospital Suspended
Calgary, Alberta, Canada, T3B 6A8
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Tanya R. Brown    306-766-2213      
Principal Investigator: Tanya R. Brown         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna M. Zelcer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Shayna M. Zelcer         
Hospital for Sick Children Suspended
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sharon B. Abish         
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Sharon B. Abish       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sharon B. Abish         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Mark A. Winstanley       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Winstanley         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Contact: Tristan Pettit    03 364 0640      
Principal Investigator: Tristan Pettit         
Puerto Rico
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pooja Hingorani Children's Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02484443     History of Changes
Other Study ID Numbers: NCI-2015-01001
NCI-2015-01001 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s16-00451
AOST1421
AOST1421 ( Other Identifier: Childrens Oncology Group )
AOST1421 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2015
First Posted: June 29, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Osteosarcoma
Neoplasms, Second Primary
Lung Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs