Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

NCT02097238 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2014-00621COG-AOST1322AOST1322U10CA180886U10CA098543
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 119

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.

Conditions

Recurrent Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Disease Control Success

  The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.

  4 Months

• 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.

  4 months

Secondary Outcomes (4)

• Number of Cycles Where a Dose Limiting Toxicity Was Identified

  4 months

• Area Under the Curve 0-infinity of Eribulin Mesylate in Ng-hr/ml

  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

• Clearance of Eribulin Mesylate in L/hr

  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.

• A Half Life of Eribulin Mesylate in hr

  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

Study Arms (1)

Treatment (eribulin mesylate)

EXPERIMENTAL

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.

Drug: Eribulin Mesylate; Other: Pharmacological Study

Interventions

Eribulin Mesylate DRUG

Given IV

Also known as: E7389, ER-086526, Halaven, Halichondrin B Analog

Treatment (eribulin mesylate)

Pharmacological Study OTHER

Correlative studies

Treatment (eribulin mesylate)

Eligibility Criteria

• Age: 12 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (119)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

Location

Children's Hospital Central California

Madera, California, 93636-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Memorial University Medical Center

Savannah, Georgia, 31404, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Michigan State University Clinical Center

East Lansing, Michigan, 48824-7016, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Central Care Cancer Center-Carrie J Babb Cancer Center

Bolivar, Missouri, 65613, United States

Location

CoxHealth Cancer Center

Branson, Missouri, 65616, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Mercy Hospital-Joplin

Joplin, Missouri, 64804, United States

Location

The Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Phelps County Regional Medical Center

Rolla, Missouri, 65401, United States

Location

Saint John's Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, 63109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cancer and Blood Specialists-Henderson

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

Location

Las Vegas Cancer Center-Henderson

Henderson, Nevada, 89052, United States

Location

21st Century Oncology - Henderson

Henderson, Nevada, 89074, United States

Location

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074, United States

Location

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, 89106, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

Location

21st Century Oncology

Las Vegas, Nevada, 89109, United States

Location

Children's Specialty Center of Nevada II

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, 89109, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, 89113, United States

Location

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119, United States

Location

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, 89121, United States

Location

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, 89148-2405, United States

Location

21st Century Oncology - Fort Apache

Las Vegas, Nevada, 89148, United States

Location

Cancer and Blood Specialists-Fort Apache

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, 89149, United States

Location

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

Location

21st Century Oncology - Vegas Tenaya

Las Vegas, Nevada, 89182, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sanford Medical Center-Fargo

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

Location

Childrens Hospital-King's Daughters

Norfolk, Virginia, 23507, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Michael Isakoff

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: August 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: March 31, 2020
• Last Updated: May 19, 2020
• Results First Posted: September 1, 2017

Record last verified: 2020-05

Locations

US (116); CA (3)