Clinical Trial - NCT03331250

Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: Eisai Inc.

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Gregory Cote Principal Investigator

ClinicalTrials.gov Identifier: NCT03331250

Protocol Info

Short Description: Phase 2 of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
Long Description: A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid hemangioendothelioma (EHE)
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Sarcoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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
Condition Title Intervention Phase
Angiosarcoma Epithelioid Hemangioendothelioma Eribulin Phase 2
Study Type Interventional
Official Title A Pilot Phase 2 Study of Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)

Primary Outcome Measures

Objective Response Rate [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Progression Free Survival [Time Frame: 4 years] [Designated as safety issue: ]

Disease Control Rate [Time Frame: 24 weeks] [Designated as safety issue: ]

Treatment Related Adverse Events [Time Frame: 4 years] [Designated as safety issue: ]

Estimated Enrollment: 16
Study Start Date: January 2018
Estimated Study Completion Date: May 2025
Estimated Primary Completion Date: May 2021
Arms Assigned Interventions

Experimental:Eribulin

Eribulin administered twice per cycle intravenously Each cycle contains 21 days Dosing is per the FDA label for other cancers
Drug:Eribulin
It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Metastatic or locally advanced angiosarcoma, treated with at least one prior systemic therapy where no standard of care curable therapy is available OR metastatic or locally advanced malignant and progressive epithelioid hemangioendothelioma (EHE).
  • A maximum of 5 EHE patients will be accrued on this study
  • Archival tissue confirming the diagnosis must be reviewed by BWH/DFCI/MGH pathology.
  • Progression on at least one prior systemic therapy or progression during an observation phase of no anti-cancer therapy within the prior 3 months; prior taxanes are allowed
  • Participants must have measurable disease by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as =20 mm with conventional techniques or as =10 mm with spiral CT scan, MRI, or calipers by clinical exam.
  • Age > 18 years.
  • ECOG performance status =2
  • Life expectancy of greater than 3 months
  • Participants must have normal organ and marrow function as defined below:
  • leukocytes =3,000/mcL
  • absolute neutrophil count =1,000/mcL
  • platelets =100,000/mcL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) =2.5 × institutional upper limit of normal
  • creatinine clearance =50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Baseline QTcF < grade 2
  • The effects of Eribulin on the developing human fetus are unknown. For this reason and because of the risk of teratogenicity, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation, and 4 months after completion of Eribulin administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Eribulin administration.
  • Willingness to undergo serial tumor biopsies before and on treatment.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), immunotherapy within 3 weeks, targeted therapies (e.g. small molecule inhibitors such as pazopanib) within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Not clinically significant or clinically stable adverse events from prior therapy (e.g. immunotherapy related hypothyroidism or insulin-dependent diabetes stable on medication or TKI-related hypertension or rash etc.) is allowed.
  • Participants who are receiving any other investigational agents.
  • Participants with known brain metastases and/or leptomeningeal disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class II), unstable angina pectoris or myocardial infarction within 6 months of enrolment, serious or life-threatening cardiac arrhythmia, subjects with a high probability of Long QT syndrome or QTcF prolongation of > 501 mcsec (grade 2) on at least two separate ECG following correction of any electrolyte imbalance or psychiatric illness/social situations that would limit compliance with study requirements.
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Eribulin. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03331250

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Eisai Inc.

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Gregory Cote Principal Investigator
ClinicalTrials.gov Identifier: NCT03331250
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Epithelioid hemangioendothelioma (EHE)

Angiosarcoma

Additional relevant MeSH terms:

Hemangiosarcoma

Hemangioendothelioma

Hemangioendothelioma, Epithelioid

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on November 12, 2020