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 |
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.
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.
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
117
sites
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Children's Hospital of Alabama Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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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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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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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
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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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
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
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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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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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
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
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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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
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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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
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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Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Denver, Colorado 80218
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4160 John R St #2122
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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4760 Sunset Blvd
Downey, California 90027
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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601 South Rancho Drive
Suite C-26
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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2450 Riverside Ave
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
(618) 242-4600
Good Samaritan Regional Health Center St. Mary's Good Samaritan, Incorporated (SMGSI) was created in 1996...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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725 Welch Rd
Palo Alto, California 94304
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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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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2801 N Gantenbein Ave
Portland, Oregon 97227
Portland, Oregon 97227
(503) 276-6500
Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
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1000 W 10th St Ste 260
Rolla, Missouri 65401
Rolla, Missouri 65401
(573) 341-9165
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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
Saint Louis, Missouri 63109
(314) 353-1870
Saint Louis Cancer and Breast Institute-South City Mercy Clinic St. Louis Cancer and Breast Institute...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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