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Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma

Primary Purpose

Recurrent Osteosarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Glembatumumab Vedotin
Laboratory Biomarker Analysis
Pharmacological Study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Osteosarcoma

Eligibility Criteria

12 Years - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse
  • Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy
  • Patient must have archival 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 chemotherapy: must not have received within 2 weeks of entry onto this study (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 RT (small port); >= 6 months 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
    • Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL
  • Platelet count >= 75,000/uL (transfusion independent)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

  • 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:

    • Age 1 to < 2 years (male and female: 0.6 mg/dL)
    • Age 2 to < 6 years (male and female: 0.8 mg/dL)
    • Age 6 to < 10 years (male and female: 1 mg/dL)
    • Age 10 to < 13 years (male and female: 1.2 mg/dL)
    • Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL)
    • Age >= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L
  • Serum albumin > 2 g/dL
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram
  • 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

Exclusion Criteria:

  • Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
  • Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents
  • Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment
  • Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent
  • Patients with known central nervous system metastasis are not eligible
  • Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
  • 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 and for 2 months after the end of study treatment

Sites / Locations

  • Children's Hospital of Alabama
  • Banner University Medical Center - Tucson
  • University of Arizona Cancer Center-North Campus
  • Arkansas Children's Hospital
  • Kaiser Permanente-Anaheim
  • PCR Oncology
  • Kaiser Permanente-Bellflower
  • Kaiser Permanente Downey Medical Center
  • Kaiser Permanente-Fontana
  • Loma Linda University Medical Center
  • Children's Hospital Los Angeles
  • Kaiser Permanente Los Angeles Medical Center
  • Mattel Children's Hospital UCLA
  • Valley Children's Hospital
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital Stanford University
  • Kaiser Permanente-San Diego Zion
  • Rady Children's Hospital - San Diego
  • UCSF Medical Center-Mission Bay
  • Children's Hospital Colorado
  • University of Colorado Hospital
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  • Connecticut Children's Medical Center
  • Smilow Cancer Center/Yale-New Haven Hospital
  • Yale University
  • Alfred I duPont Hospital for Children
  • Kaiser Permanente-Capitol Hill Medical Center
  • Children's National Medical Center
  • Sibley Memorial Hospital
  • Golisano Children's Hospital of Southwest Florida
  • University of Florida Health Science Center - Gainesville
  • Nemours Children's Clinic-Jacksonville
  • Nicklaus Children's Hospital
  • AdventHealth Orlando
  • Nemours Children's Hospital
  • Nemours Children's Clinic - Pensacola
  • Johns Hopkins All Children's Hospital
  • Tampa General Hospital
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Saint Mary's Hospital
  • Children's Healthcare of Atlanta - Egleston
  • Saint Luke's Cancer Institute - Boise
  • Rush - Copley Medical Center
  • Lurie Children's Hospital-Chicago
  • University of Chicago Comprehensive Cancer Center
  • Carle on Vermilion
  • Carle Physician Group-Effingham
  • Carle Physician Group-Mattoon/Charleston
  • Saint Jude Midwest Affiliate
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Rush-Copley Healthcare Center
  • IU Health North Hospital
  • Riley Hospital for Children
  • Memorial Hospital of South Bend
  • University of Iowa/Holden Comprehensive Cancer Center
  • University of Kentucky/Markey Cancer Center
  • Ochsner Medical Center Jefferson
  • Sinai Hospital of Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber Cancer Institute
  • C S Mott Children's Hospital
  • University of Michigan Comprehensive Cancer Center
  • Wayne State University/Karmanos Cancer Institute
  • Ascension Saint John Hospital
  • Lake Huron Medical Center
  • University of Minnesota/Masonic Cancer Center
  • Mayo Clinic in Rochester
  • University of Mississippi Medical Center
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Children's Mercy Hospitals and Clinics
  • Delbert Day Cancer Institute at PCRMC
  • Saint Louis Cancer and Breast Institute-South City
  • Washington University School of Medicine
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Mercy Hospital Washington
  • Carson Tahoe Regional Medical Center
  • Cancer and Blood Specialists-Henderson
  • Comprehensive Cancer Centers of Nevada - Henderson
  • Las Vegas Cancer Center-Henderson
  • 21st Century Oncology-Henderson
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
  • Cancer and Blood Specialists-Shadow
  • Radiation Oncology Centers of Nevada Central
  • 21st Century Oncology
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
  • Radiation Oncology Centers of Nevada Southeast
  • Cancer Therapy and Integrative Medicine
  • 21st Century Oncology-Vegas Tenaya
  • Ann M Wierman MD LTD
  • Cancer and Blood Specialists-Tenaya
  • Comprehensive Cancer Centers of Nevada - Northwest
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Summerlin Hospital Medical Center
  • Las Vegas Cancer Center-Medical Center
  • 21st Century Oncology-Fort Apache
  • Comprehensive Cancer Centers of Nevada
  • OptumCare Cancer Care at Fort Apache
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • Renown Regional Medical Center
  • Saint Mary's Regional Medical Center
  • Dartmouth Hitchcock Medical Center
  • Hackensack University Medical Center
  • Albany Medical Center
  • Montefiore Medical Center-Einstein Campus
  • Montefiore Medical Center-Weiler Hospital
  • Children's Hospital at Montefiore
  • Montefiore Medical Center - Moses Campus
  • NYU Winthrop Hospital
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • State University of New York Upstate Medical University
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's Hospital
  • Dayton Children's Hospital
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia
  • Children's Oncology Group
  • Children's Hospital of Pittsburgh of UPMC
  • Sanford USD Medical Center - Sioux Falls
  • Vanderbilt-Ingram Cancer Center Cool Springs
  • East Tennessee Childrens Hospital
  • Saint Jude Children's Research Hospital
  • Vanderbilt Breast Center at One Hundred Oaks
  • Vanderbilt University/Ingram Cancer Center
  • Dell Children's Medical Center of Central Texas
  • Medical City Dallas Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Cook Children's Medical Center
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
  • Methodist Children's Hospital of South Texas
  • University Hospital
  • University of Texas Health Science Center at San Antonio
  • Children's Hospital of The King's Daughters
  • Seattle Children's Hospital
  • Fred Hutchinson Cancer Research Center
  • University of Washington Medical Center - Montlake
  • Providence Sacred Heart Medical Center and Children's Hospital
  • Children's Hospital of Wisconsin
  • Alberta Children's Hospital
  • CancerCare Manitoba
  • IWK Health Centre
  • The Montreal Children's Hospital of the MUHC
  • Centre Hospitalier Universitaire de Quebec
  • University Pediatric Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (glembatumumab vedotin)

Arm Description

Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Disease Control Success
The number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521

Secondary Outcome Measures

Toxicity Associated With Chemotherapy
The number of cycles aggregated across all patients where CTC Version 4 grade 3 or higher.
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life
Total antibody and antibody-drug conjugate half-life are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance
Total antibody and antibody-drug conjugate clearance are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve
Total antibody and antibody-drug conjugate areas under the curve are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
GPNMB expression by IHC of 0+ to 3+ staining strength as assessed on archived tumor specimens. 0 being no GPNMB expression and 3 indicating strong GPNMB expression.
RECIST Response
The number of patients who experience a complete or partial response according the RECIST criteria for target lesions complete response (CR) disappearance of all lesions; partial response (PR ) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.

Full Information

First Posted
July 1, 2015
Last Updated
January 6, 2022
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02487979
Brief Title
Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
Official Title
A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate, CDX-011 (Glembatumumab Vedotin, CR011-vcMMAE; NSC# 763737), in Recurrent or Refractory Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate whether CDX-011 (glembatumumab vedotin) therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to an historical Children's Oncology Group (COG) experience or produces an objective response rate in patients without previous eribulin (eribulin mesylate) treatment. SECONDARY OBJECTIVES: I. To assess the feasibility and toxicity profile of CDX-011 in patients with recurrent osteosarcoma. II. To describe the pharmacokinetics of CDX-011 in adolescents and young adults with recurrent osteosarcoma enrolled at COG sites and COG phase I consortium sites only. III. To determine if there is a relationship between tumor GPNMB expression by immunohistochemistry (IHC) and response to CDX-011 therapy. IV. To estimate, in the cohort of patients previously treated with eribulin, the proportion who will experience disease progression during the first 4 months of CDX-011 therapy and the proportion of patients who experience a Response Evaluation Criteria in Solid Tumors (RECIST)-defined complete or partial response. OUTLINE: Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Osteosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (glembatumumab vedotin)
Arm Type
Experimental
Arm Description
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Glembatumumab Vedotin
Other Intervention Name(s)
Antibody-Drug Conjugate CR011-vcMMAE, CDX-011, CR011-vcMMAE, CR011-vcMMAE Immunotoxin
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Disease Control Success
Description
The number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521
Time Frame
First six cycles (21-day cycle) of protocol therapy
Secondary Outcome Measure Information:
Title
Toxicity Associated With Chemotherapy
Description
The number of cycles aggregated across all patients where CTC Version 4 grade 3 or higher.
Time Frame
Duration of protocol therapy - Up to two years
Title
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life
Description
Total antibody and antibody-drug conjugate half-life are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Time Frame
Baseline to 24 hours post infusion on course 1
Title
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance
Description
Total antibody and antibody-drug conjugate clearance are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Time Frame
Baseline to 24 hours post infusion on course 1
Title
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve
Description
Total antibody and antibody-drug conjugate areas under the curve are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion
Time Frame
Baseline to 24 hours post infusion on course 1
Title
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
Description
GPNMB expression by IHC of 0+ to 3+ staining strength as assessed on archived tumor specimens. 0 being no GPNMB expression and 3 indicating strong GPNMB expression.
Time Frame
Prior to the time of enrollment
Title
RECIST Response
Description
The number of patients who experience a complete or partial response according the RECIST criteria for target lesions complete response (CR) disappearance of all lesions; partial response (PR ) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
Time Frame
First six cycles (21-day cycle) of protocol therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy Patient must have archival 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 chemotherapy: must not have received within 2 weeks of entry onto this study (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 RT (small port); >= 6 months 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 Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment Peripheral absolute neutrophil count (ANC) >= 1000/uL Platelet count >= 75,000/uL (transfusion independent) Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) 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: Age 1 to < 2 years (male and female: 0.6 mg/dL) Age 2 to < 6 years (male and female: 0.8 mg/dL) Age 6 to < 10 years (male and female: 1 mg/dL) Age 10 to < 13 years (male and female: 1.2 mg/dL) Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL) Age >= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L Serum albumin > 2 g/dL Shortening fraction of >= 27% by echocardiogram, or Ejection fraction of >= 50% by radionuclide angiogram 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 Exclusion Criteria: Patients with > grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent Patients with known central nervous system metastasis are not eligible Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery 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 and for 2 months after the end of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Kopp
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Facility Name
Kaiser Permanente-Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Kaiser Permanente Downey Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Kaiser Permanente-Fontana
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Mattel Children's Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Permanente-San Diego Zion
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Smilow Cancer Center/Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Kaiser Permanente-Capitol Hill Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Golisano Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Nemours Children's Clinic - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Saint Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Facility Name
IU Health North Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Lake Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Carson Tahoe Regional Medical Center
City
Carson City
State/Province
Nevada
ZIP/Postal Code
89703
Country
United States
Facility Name
Cancer and Blood Specialists-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Las Vegas Cancer Center-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
21st Century Oncology-Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Southeast Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Cancer and Blood Specialists-Shadow
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
21st Century Oncology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-San Martin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Southeast
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Cancer Therapy and Integrative Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
21st Century Oncology-Vegas Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Ann M Wierman MD LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Cancer and Blood Specialists-Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Northwest
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada-Summerlin
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Summerlin Hospital Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Las Vegas Cancer Center-Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148-2405
Country
United States
Facility Name
21st Century Oncology-Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
OptumCare Cancer Care at Fort Apache
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89149
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center-Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center Cool Springs
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
East Tennessee Childrens Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
31586757
Citation
Kopp LM, Malempati S, Krailo M, Gao Y, Buxton A, Weigel BJ, Hawthorne T, Crowley E, Moscow JA, Reid JM, Villalobos V, Randall RL, Gorlick R, Janeway KA. Phase II trial of the glycoprotein non-metastatic B-targeted antibody-drug conjugate, glembatumumab vedotin (CDX-011), in recurrent osteosarcoma AOST1521: A report from the Children's Oncology Group. Eur J Cancer. 2019 Nov;121:177-183. doi: 10.1016/j.ejca.2019.08.015. Epub 2019 Oct 3.
Results Reference
derived
PubMed Identifier
31401903
Citation
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
Results Reference
derived

Learn more about this trial

Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma

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