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Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

Primary Purpose

Recurrent Osteosarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eribulin Mesylate
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
  • Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria, and have relapsed or become refractory to conventional therapy
  • 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 a life expectancy of >= 8 weeks

  • 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 (6 weeks if prior nitrosourea)
    • Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent
    • Bisphosphonates: at least 4 weeks since the completion of therapy with a bisphosphonate
    • Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
    • Radiation therapy (RT): >= 2 weeks (wks) 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
  • 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: (threshold creatinine values were derived from the Schwartz formula for estimating GFR)

    • Age (12 to < 13 years) - serum creatinine of 1.2 mg/dL
    • Age (13 to < 16 years) - serum creatinine of 1.5 mg/dL (male) and 1.4 mg/dL (female)
    • Age (>= 16 years) - serum creatinine of 1.7 mg/dL (male) and 1.4 mg/dL (female)
  • Bilirubin (sum of conjugate + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 units per liter (U/L); for the purpose of this study, the ULN for SGPT is 45 U/L
  • Serum albumin > 2 g/dL
  • Shortening fraction of >= 27% by echocardiogram
  • 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 congenital prolonged QT syndrome
  • Patients with a baseline QT/corrected QT (QTc) interval >= 501 msec
  • Patients who are receiving drugs that prolong the QTc are not eligible
  • Patients who have previously received eribulin, halichondrin B, or analogues of halichondrin B
  • Patients who have grade >= 2 peripheral neuropathy
  • Patients who are receiving other cancer directed therapy at the time of enrollment
  • Patients who have had major surgery within 3 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

  • Pregnancy and breast feeding

    • 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

Sites / Locations

  • Children's Hospital of Alabama
  • Phoenix Childrens Hospital
  • Southern California Permanente Medical Group
  • Loma Linda University Medical Center
  • Children's Hospital Los Angeles
  • Mattel Children's Hospital UCLA
  • Children's Hospital Central California
  • Children's Hospital and Research Center at Oakland
  • Kaiser Permanente-Oakland
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital Stanford University
  • University of California Davis Comprehensive Cancer Center
  • Children's Hospital Colorado
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  • Connecticut Children's Medical Center
  • Alfred I duPont Hospital for Children
  • Children's National Medical Center
  • Nemours Children's Clinic-Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Nemours Children's Hospital
  • Nemours Children's Clinic - Pensacola
  • All Children's Hospital
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Saint Mary's Hospital
  • Children's Healthcare of Atlanta - Egleston
  • Memorial University Medical Center
  • Lurie Children's Hospital-Chicago
  • University of Illinois
  • University of Chicago Comprehensive Cancer Center
  • Good Samaritan Regional Health Center
  • Advocate Children's Hospital-Oak Lawn
  • Saint Jude Midwest Affiliate
  • Riley Hospital for Children
  • Saint Vincent Hospital and Health Care Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Siouxland Regional Cancer Center
  • University of Kentucky/Markey Cancer Center
  • Ochsner Medical Center Jefferson
  • Maine Children's Cancer Program
  • Sinai Hospital of Baltimore
  • Wayne State University/Karmanos Cancer Institute
  • Michigan State University Clinical Center
  • Essentia Health Cancer Center
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • University of Minnesota Medical Center-Fairview
  • Mayo Clinic
  • University of Mississippi Medical Center
  • Central Care Cancer Center-Carrie J Babb Cancer Center
  • CoxHealth Cancer Center
  • Freeman Health System
  • Mercy Hospital-Joplin
  • The Childrens Mercy Hospital
  • Phelps County Regional Medical Center
  • Saint John's Clinic-Rolla-Cancer and Hematology
  • Saint Louis Cancer and Breast Institute-South City
  • Washington University School of Medicine
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Children's Hospital and Medical Center of Omaha
  • University of Nebraska 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
  • Nevada Cancer Research Foundation CCOP
  • Radiation Oncology Centers of Nevada Central
  • 21st Century Oncology
  • Children's Specialty Center of Nevada II
  • 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
  • Cancer and Blood Specialists-Tenaya
  • Comprehensive Cancer Centers of Nevada - Northwest
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Summerlin Hospital Medical Center
  • Las Vegas Cancer Center-Medical Center
  • 21st Century Oncology - Fort Apache
  • Cancer and Blood Specialists-Fort Apache
  • Comprehensive Cancer Centers of Nevada
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • 21st Century Oncology - Vegas Tenaya
  • Montefiore Medical Center - Moses Campus
  • The Steven and Alexandra Cohen Children's Medical Center of New York
  • Columbia University Medical Center
  • State University of New York Upstate Medical University
  • Mission Hospital-Memorial Campus
  • Duke University Medical Center
  • Sanford Medical Center-Fargo
  • Children's Hospital Medical Center of Akron
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Childrens Hospital
  • Nationwide Children's Hospital
  • The Toledo Hospital/Toledo Children's Hospital
  • Legacy Emanuel Children's Hospital
  • Oregon Health and Science University
  • Lehigh Valley Hospital - Muhlenberg
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • Palmetto Health Richland
  • Sanford USD Medical Center - Sioux Falls
  • East Tennessee Childrens Hospital
  • St. Jude Children's Research Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Cook Children's Medical Center
  • Baylor College of Medicine
  • Children's Hospital of San Antonio
  • Childrens Hospital-King's Daughters
  • Seattle Children's Hospital
  • Providence Sacred Heart Medical Center and Children's Hospital
  • West Virginia University Healthcare
  • British Columbia Children's Hospital
  • CancerCare Manitoba
  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (eribulin mesylate)

Arm Description

Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months 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 four months following enrollment on AOST1322.
Response Evaluation Criteria in Solid Tumors (RECIST) Response
The number of patients who experience a complete or partial response according to the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.

Secondary Outcome Measures

Number of Cycles Where a Dose Limiting Toxicity Was Identified
Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: day 8 eribulin dose is held due to grade 3 or grade 4 non-hematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by day 11. Any >= grade 3 non-hematological toxicity attributable to the investigational drug with the specific exclusion of: grade 3 nausea and vomiting < 3 days duration grade 3 liver enzyme elevation, including alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/gamma-glutamyltransferase (GGT), that returns to grade =< 1 or baseline prior to the time for the next treatment cycle.
Area Under the Curve 0-infinity of Eribulin Mesylate in Ng-hr/ml
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve will be reported The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
Clearance of Eribulin Mesylate in L/hr
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the clearance will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
A Half Life of Eribulin Mesylate in hr
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the half life will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.

Full Information

First Posted
March 24, 2014
Last Updated
May 4, 2020
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02097238
Brief Title
Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma
Official Title
A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well eribulin mesylate works in treating patients with osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth of tumor cells by disrupting the cell cycle.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the 4 month progression free survival rate and objective response rate in patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate) therapy on day 1 and day 8 of 21 day cycles. SECONDARY OBJECTIVES: I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent osteosarcoma. II. To further describe the tolerability of single agent eribulin. OUTLINE: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up annually for 5 years.

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
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (eribulin mesylate)
Arm Type
Experimental
Arm Description
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Eribulin Mesylate
Other Intervention Name(s)
E7389, ER-086526, Halaven, Halichondrin B Analog
Intervention Description
Given IV
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 four months following enrollment on AOST1322.
Time Frame
4 Months
Title
Response Evaluation Criteria in Solid Tumors (RECIST) Response
Description
The number of patients who experience a complete or partial response according to the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Number of Cycles Where a Dose Limiting Toxicity Was Identified
Description
Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: day 8 eribulin dose is held due to grade 3 or grade 4 non-hematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by day 11. Any >= grade 3 non-hematological toxicity attributable to the investigational drug with the specific exclusion of: grade 3 nausea and vomiting < 3 days duration grade 3 liver enzyme elevation, including alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/gamma-glutamyltransferase (GGT), that returns to grade =< 1 or baseline prior to the time for the next treatment cycle.
Time Frame
4 months
Title
Area Under the Curve 0-infinity of Eribulin Mesylate in Ng-hr/ml
Description
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve will be reported The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
Time Frame
Cycle 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion
Title
Clearance of Eribulin Mesylate in L/hr
Description
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the clearance will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
Time Frame
Cycle 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion.
Title
A Half Life of Eribulin Mesylate in hr
Description
Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the half life will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
Time Frame
1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion

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 Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria, and have relapsed or become refractory to conventional therapy 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 a life expectancy of >= 8 weeks 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 (6 weeks if prior nitrosourea) Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent Bisphosphonates: at least 4 weeks since the completion of therapy with a bisphosphonate Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody Radiation therapy (RT): >= 2 weeks (wks) 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 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: (threshold creatinine values were derived from the Schwartz formula for estimating GFR) Age (12 to < 13 years) - serum creatinine of 1.2 mg/dL Age (13 to < 16 years) - serum creatinine of 1.5 mg/dL (male) and 1.4 mg/dL (female) Age (>= 16 years) - serum creatinine of 1.7 mg/dL (male) and 1.4 mg/dL (female) Bilirubin (sum of conjugate + unconjugated) =< 1.5 x upper limit of normal (ULN) for age Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 units per liter (U/L); for the purpose of this study, the ULN for SGPT is 45 U/L Serum albumin > 2 g/dL Shortening fraction of >= 27% by echocardiogram 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 congenital prolonged QT syndrome Patients with a baseline QT/corrected QT (QTc) interval >= 501 msec Patients who are receiving drugs that prolong the QTc are not eligible Patients who have previously received eribulin, halichondrin B, or analogues of halichondrin B Patients who have grade >= 2 peripheral neuropathy Patients who are receiving other cancer directed therapy at the time of enrollment Patients who have had major surgery within 3 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 Pregnancy and breast feeding 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Isakoff
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
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242
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
Mattel Children's Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93636-8762
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
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
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Children's Hospital Colorado
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
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
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
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
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
Memorial University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
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 Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Advocate Children's Hospital-Oak Lawn
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saint Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
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
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
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
Michigan State University Clinical Center
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824-7016
Country
United States
Facility Name
Essentia Health Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Medical Center-Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
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
Central Care Cancer Center-Carrie J Babb Cancer Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
CoxHealth Cancer Center
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Hospital-Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
The Childrens Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Phelps County Regional Medical Center
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Saint John's Clinic-Rolla-Cancer and Hematology
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
Children's Hospital and Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
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
Nevada Cancer Research Foundation CCOP
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
Children's Specialty Center of Nevada II
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
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
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
Cancer and Blood Specialists-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
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
21st Century Oncology - Vegas Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89182
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
The Steven and Alexandra Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Columbia University Medical 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
Mission Hospital-Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sanford Medical Center-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
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
Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Toledo Hospital/Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Legacy Emanuel Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
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 Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
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
East Tennessee Childrens Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
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
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Childrens Hospital-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
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

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Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

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