Eribulin for Hemangiosarcoma and Epithelioid Hemangioendothelioma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Eribulin (also known as Halaven), a drug that may help treat two rare types of cancer: Angiosarcoma and Epithelioid Hemangioendothelioma (EHE). The goal is to determine if Eribulin can effectively manage these cancers, especially for those who haven't succeeded with other treatments. People with advanced stages of these cancers who have tried at least one other treatment and still experience disease progression might be suitable for this study. Participants will receive Eribulin intravenously in a set cycle to monitor its effects.

As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Eribulin has been studied for its safety in people with cancer. In earlier studies involving patients with various cancer types, common side effects included low white blood cell counts (neutropenia), tiredness, hair loss, and anemia (low red blood cell count). These side effects occurred in more than 25% of patients.

While researchers are testing Eribulin for Angiosarcoma and Epithelioid Hemangioendothelioma, the FDA has already approved it for other cancers. This approval indicates that its safety is somewhat understood. However, reactions to the treatment can vary among individuals. Before joining a trial, discussing potential risks with a healthcare professional is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for angiosarcoma or epithelioid hemangioendothelioma?

Eribulin is unique because it targets cancer cells by inhibiting their microtubule dynamics, which is crucial for cell division. Unlike the standard chemotherapy options for hemangiosarcoma and epithelioid hemangioendothelioma, which often involve drugs like doxorubicin or ifosfamide, Eribulin is derived from a marine sponge, offering a novel mechanism of action. Researchers are excited about Eribulin because it has shown promise in other types of cancer for improving survival rates, and it could offer a new, effective option for patients with these rare and aggressive vascular tumors.

What evidence suggests that Eribulin might be an effective treatment for Angiosarcoma or Epithelioid hemangioendothelioma?

Research has shown that Eribulin, the treatment under study in this trial, may help treat angiosarcoma and epithelioid hemangioendothelioma (EHE). In studies, about 7.5% of patients experienced tumor shrinkage, known as a partial response. Additionally, 34.5% of patients maintained stable disease, meaning their cancer did not progress during the study. Eribulin stops cancer cells from dividing, potentially slowing or halting tumor growth. These findings suggest that Eribulin could effectively manage these rare cancers. ^{1 2 3 4 6}

Who Is on the Research Team?

Gregory Cote, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03331250

NCT03331250 | Eribulin in Angiosarcoma and Epithelioid ...

Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. " ...

2.

withpower.com

withpower.com/trial/phase-3-hemangiosarcoma-2018-ac881?lat=34.60184&lng=-117.81218

Eribulin for Hemangiosarcoma and Epithelioid ...

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

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6886464/

Interim results of a real-world observational study ...

Among patients with imaging data, best overall tumor response (12 weeks) was partial response, 7.5% (n = 17); stable disease, 34.5% (n = 78); ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8182432/

Epithelioid hemangioendothelioma, an ultra-rare cancer

Retrospective data suggest that percutaneous ablation (RFA/MWA) can be safe and useful to treat a single and small EHE with curative intent., ...

5.

dana-farber.org

dana-farber.org/clinical-trials/17-355

A Pilot Phase 2 Study of Eribulin in Angiosarcoma and and ...

This research study is studying a drug as a possible treatment for Angiosarcoma or Epithelioid hemangioendothelioma (EHE).

6.

halaven.com

halaven.com/hcp/advanced-liposarcoma/efficacy

Phase III Trial Results & Efficacy

In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), ...