Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    28
  • sponsor
    Thomas Jefferson University
Updated on 26 October 2021

Summary

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.

Description

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.

OUTLINE

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.

Details
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 IdentifierNCT04728633
SponsorThomas Jefferson University
Last Modified on26 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed metastatic uveal melanoma in the liver
Tumor burden < 75%. Patients must have at least one tumor measuring >= 10 mm in longest diameter by magnetic resonance imaging (MRI) or triphasic computed tomography (CT) (if MRI is not available or contraindicated)
No prior transarterial catheter-directed therapies. Prior hepatic tumor ablation, hepatic radiation or liver resection will be permitted as long as growing measurable liver tumors exists. Prior systemic treatments are allowed as long as there are no outstanding toxicities greater than grade 1
Willingness and ability to give informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Serum creatinine =< 2.0 mg/dl
Bilirubin =< 2.0 mg/ml. Exceptions will be made for patients with diagnosed Gilbert's Syndrome. In this instance, a bilirubin level =< 3.0 mg/ml will be allowed for this patients with this syndrome
Albumin >= 3.0 g/dl
No ascites
Granulocyte count >= 1500/m^3
Platelet count >= 150,000/m^3

Exclusion Criteria

Less than 18 years of age
Previous liver-directed treatments including immunoembolization, chemoembolization, radioembolization, hepatic arterial perfusion, or drug-eluting beads
Presence of life-limiting extrahepatic metastasis that requires systemic treatment within 3 months. However, radiation treatment of extrahepatic metastases such as bone, lymph nodes or subcutaneous metastases will be permitted while the patient is on study. Zometa or X-Geva to treat bone metastases will also be permitted. Immune check-point inhibitors while on study will NOT be permitted
Portal vein occlusion, or inadequate collateral portal venous flow, as determined by MRI
Known active viral or autoimmune hepatitis requiring treatments with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) equal or greater than 5 times normal
Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry
Presence of any other medical conditions that imply a survival of less than six months
Uncontrolled severe bleeding tendency or active gastrointestinal (GI) bleeding due to varices or main portal vein occlusion. Abnormal coagulation test must be corrected prior to the procedure
History of life-threatening allergic reaction to iodinated contrast or BCNU despite pre-treatment with steroids
Pregnant and/or breastfeeding women
Presence of known untreated brain metastases. If patients have had previous treatment for brain metastasis, an MRI or CT of the brain must confirm the stabilization of the brain metastasis for more than 4 weeks
Biliary obstruction, biliary stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If 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 more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every 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

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

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!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note