This research study is studying a drug as a possible treatment for Angiosarcoma or Epithelioid hemangioendothelioma (EHE). -The drug involved in this study is Eribulin
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved Eribulin for your specific disease but it has been approved for other uses. In this research study, the investigators are studying how safe and effective eribulin is in participants with Angiosarcoma or EHE. Eribulin was created to mimic the structure of a chemical that is released from a sea sponge. The investigators believe that this drug has anti-cancer effects on tumors by blocking proteins called microtubules, among other functions. It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die similar to other drugs that target microtubules
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Objective Response Rate (ORR)
The ORR is defined as the percentage of patients who achieved a partial response or complete response by RECIST 1.1. Tumor imaging studies were completed using either CT (Computed Tomography) or MRI (Magnetic resonance imaging). The modality chosen for any individual patient was the same from baseline until the end of their time on study. Per RECIST v 1.1, complete response (CR) is defined as the disappearance of all target lesions and the reduction in any pathological lymph nodes in short axis to less than 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions compared with baseline. Progressive disease (PD) is defined as a 20% increase (5+ mm absolute increase) compared with the smallest sum on study. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor PD.
Time frame: 2 years
Progression Free Survival
Time frame: 4 years
Disease Control Rate
Objective Response plus Stable Disease Rate at 24 weeks
Time frame: 24 weeks
Treatment Related Adverse Events
Summary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
Time frame: 4 years
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