Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma



Status:Completed
Healthy:No
Age Range:12 - 49
Updated:4/21/2016
Start Date:August 2014
End Date:July 2015

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A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma

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.

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.

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
We found this trial at
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1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
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Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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9300 Valley Children's Pl
Madera, California 93720
(559) 353-3000
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
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Asheville, North Carolina 28801
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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1501 North Oakland Drive
Bolivar, Missouri 65613
417-326-7200
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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Branson, Missouri 65616
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Chicago, Illinois 60614
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
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4160 John R St #2122
Detroit, Michigan 48201
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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Duluth, Minnesota 55805
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Lansing, Michigan 48824
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Henderson, Nevada 89074
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Henderson, Nevada 89052
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Henderson, Nevada 89052
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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Joplin, Missouri 64804
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Las Vegas, Nevada 89148
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, Nevada 89144
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
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Las Vegas, Nevada 89109
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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Los Angeles, California 90095
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
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Morgantown, West Virginia 26505
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
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New Orleans, Louisiana 70121
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630 W 168th St
New York, New York
212-305-2862
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Oak Lawn, Illinois 60453
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Oakland, California 94611
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8200 Dodge St
Omaha, Nebraska 68114
(402) 955-5400
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Emile St
Omaha, Nebraska 68198
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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1919 E Thomas Rd
Phoenix, Arizona 85006
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
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Rochester, Minnesota 55905
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1000 W 10th St Ste 260
Rolla, Missouri 65401
(573) 341-9165
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1000 W 10th St
Rolla, Missouri 65401
(573) 458-8899
Phelps County Regional Medical Center Phelps County Regional Medical Center is a world-class healthcare facility...
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6435 Chippewa Street
Saint Louis, Missouri 63109
(314) 353-1870
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Saint Louis, Missouri 63141
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