This phase II trial studies the effect of transarterial chemoembolization in treating patients with uveal melanoma that has spread to the liver (liver metastases). Transarterial chemoembolization involves the injection of a blocking agent (gelatin sponge, ethiodized oil) and a chemotherapy agent (carmustine) directly into the artery in the liver to treat liver cancers. Chemotherapy drugs, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. transarterial chemoembolization with carmustine in combination with ethiodized oil and gelatin sponge may help cause the tumors in the liver to shrink or disappear.
PRIMARY OBJECTIVE:
To determine the efficacy (clinical response) in terms of disease control rate (DCR) (complete response [CR] + partial response [PR] + stable disease [SD]) with chemoembolization of hepatic metastases with 300 mg of carmustine (BCNU) in ethiodized oil in metastatic uveal melanoma patients.
SECONDARY OBJECTIVES:
To investigate overall survival (OS) and progression-free survival (PFS) in uveal melanoma patients with hepatic metastases.
To assess the toxicity of the above treatment regimen.
Patients undergo transarterial chemoembolization (TACE) by receiving an infusion of carmustine dissolved in ethiodized oil and an injection of gelatin sponge. Treatment repeats once every 4 weeks (Q4W) for bilobar disease or once every 7 weeks (Q7W) for unilobar disease in the absence of disease progression or unacceptable toxicity or until maximum clinical benefit is obtained.
After completion of study treatment, patients are followed up at 30 days, and then every 2 months for up to 2 years.
Condition | Secondary Malignant Neoplasm of Liver, Metastatic Uveal Melanoma, Hepatic Metastases, Liver Metastases, Stage IV Choroidal and Ciliary Body Melanoma AJCC V8, Liver Metastasis, Metastatic Malignant Neoplasm in the Liver |
---|---|
Treatment | carmustine, Transarterial Chemoembolization, Medical Device Usage and Evaluation, Ethiodized Oil |
Clinical Study Identifier | NCT04728633 |
Sponsor | Thomas Jefferson University |
Last Modified on | 26 October 2021 |
,
You have contacted , on
Your message has been sent to the study team at ,
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreEvery year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Congrats! You have your own personal workspace now.