Eribulin for Hemangiosarcoma and Epithelioid Hemangioendothelioma

Recruiting at 1 trial location

Overseen By Kristen Finn, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Brain metastases, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

13 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy, radiotherapy, or certain other treatments within a few weeks before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Eribulin for treating hemangiosarcoma and epithelioid hemangioendothelioma?

Eribulin has shown effectiveness in treating various types of soft tissue sarcomas, including liposarcoma and angiosarcoma, with some studies indicating improved survival rates. A specific case reported success in treating a heavily pretreated cardiac angiosarcoma, suggesting potential benefits for similar conditions. ^{1 2 3 4 5}

Is Eribulin generally safe for human use?

Eribulin has been used to treat metastatic breast cancer and advanced soft-tissue sarcomas, but severe side effects occur in 30-40% of patients, including neutropenia (a drop in white blood cells), which can lead to treatment delays or dose reductions. Common side effects also include fatigue and weakness. ^{6 7 8 9 10}

How is the drug Eribulin unique for treating hemangiosarcoma and epithelioid hemangioendothelioma?

Eribulin is unique because it is a microtubule inhibitor, which means it works by stopping cancer cells from dividing and growing. This mechanism is different from other treatments like antiangiogenics or immunotherapies, which target blood vessel growth or the immune system, respectively. Since there are no standard treatments for these rare tumors, Eribulin offers a novel approach. ^{11 12 13 14 15}

What is the purpose of this trial?

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

Research Team

Gregory Cote, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with advanced angiosarcoma or epithelioid hemangioendothelioma (EHE) who've had at least one prior treatment. They must have measurable disease, a life expectancy over three months, and normal organ/marrow function. Women of childbearing age and men must use contraception. Those with brain metastases, certain heart conditions, or uncontrolled illnesses can't join.

Inclusion Criteria

You are expected to live for at least 3 more months.

My cancer has worsened after treatment or during a no-treatment phase in the last 3 months.

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. 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

Exclusion Criteria

I am not pregnant or breastfeeding.

I haven't had chemotherapy, radiotherapy, or targeted therapies recently and have recovered from any serious side effects.

I have brain metastases or leptomeningeal disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Eribulin administered twice per cycle intravenously, with each cycle containing 21 days

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Long-term follow-up

Participants are monitored for treatment-related adverse events

4 years

Treatment Details

Interventions

• Eribulin

Trial Overview The study tests Eribulin as a potential treatment for Angiosarcoma or Epithelioid Hemangioendothelioma (EHE). Participants will receive Eribulin after having progressed on previous therapies. The trial includes tumor biopsies before and during treatment to assess the drug's effect.

Participant Groups

Group I: Eribulin Experimental Treatment 1 Intervention

* Eribulin administered twice per cycle intravenously * Each cycle contains 21 days * Dosing is per the FDA label for other cancers

Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Halaven for:

• Locally advanced or metastatic breast cancer

Approved in United States as Halaven for:

• Metastatic breast cancer
• Liposarcoma

Approved in Japan as Halaven for:

• Breast cancer
• Soft tissue sarcoma

Approved in Canada as Halaven for:

• Metastatic breast cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

A comparison of 551 patients from a healthcare claims database and 951 patients from a conventional post-marketing surveillance study showed that while patient characteristics and drug use were similar, there were significant differences in the reported adverse events (AEs) for eribulin mesylate, particularly for nausea and neutropenia.

The study suggests that healthcare claims databases can effectively complement traditional post-marketing surveillance in monitoring the safety profile of eribulin, but highlights the need for better definitions of AEs like neutropenia based on laboratory data to improve accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study. Sakata, Y., Matsuoka, T., Ohashi, S., et al.[2020]

Eribulin, a microtubule dynamics inhibitor, has been approved for treating locally advanced or metastatic breast cancer in patients who have already undergone at least two chemotherapy regimens, showing a median overall survival increase from 10.6 months to 13.2 months compared to control.

The recommended dosing regimen for eribulin is 1.23 mg/m² administered intravenously on days 1 and 8 of a 3-week cycle, with common side effects including fatigue and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. Pean, E., Klaar, S., Berglund, EG., et al.[2016]

Eribulin mesylate is an FDA-approved treatment for patients with metastatic breast cancer who have already undergone at least two chemotherapy regimens, including an anthracycline and a taxane.

This drug is specifically designed for patients whose cancer has not responded to previous treatments, providing a new option for those with anthracycline- and taxane-refractory metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eribulin mesylate (Halaven) for breast cancer. [2016]

In a study of 91 taxane-refractory metastatic breast cancer patients, eribulin demonstrated clinical benefit in 45.2% of patients, with a median overall survival of 11.6 months.

Eribulin was generally well tolerated, although common side effects included fatigue (58%) and neutropenia (30%), leading to dose reductions in 19 patients and treatment suspension in 9.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of eribulin in taxane-refractory patients in the 'real world'. Lorusso, V., Cinieri, S., Latorre, A., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Eribulin therapy for the treatment of patients with advanced soft tissue sarcoma. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of eribulin mesylate in advanced soft tissue sarcomas. [2022]

3. England pubmed.ncbi.nlm.nih.gov

In vivo imaging of eribulin-induced reoxygenation in advanced breast cancer patients: a comparison to bevacizumab. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Eribulin in Soft Tissue Sarcomas. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A case of heavily pretreated metastatic cardiac angiosarcoma treated successfully using eribulin. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study. [2020]

7. Greece pubmed.ncbi.nlm.nih.gov

Risk Factor Analysis for the Occurrence of Severe Adverse Effects in Eribulin Treatment. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Eribulin mesylate (Halaven) for breast cancer. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of eribulin in taxane-refractory patients in the 'real world'. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Rare case of epithelioid hemangioendothelioma in the right innominate vein-An innovative diagnostic approach. [2022]

12. England pubmed.ncbi.nlm.nih.gov

68Ga-DOTA-E-[c(RGDfK)]2 positron emission tomography-computed tomography in the evaluation of hepatic hemangioendothelioma epithelioid. [2020]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Metastatic Hepatic Epithelioid Hemangioendothelioma Treated with Olaratumab: A Falling Star Rising? [2020]

14. United States pubmed.ncbi.nlm.nih.gov

New Molecular Insights, and the Role of Systemic Therapies and Collaboration for Treatment of Epithelioid Hemangioendothelioma (EHE). [2023]

15. England pubmed.ncbi.nlm.nih.gov

Eight years tumor control with pazopanib for a metastatic resistant epithelioid hemangioendothelioma. [2022]