Intervention: Eribulin
Trial phase: Phase 2
ATC code: L01XX41
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Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 19
Group 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.
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