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Alkylating agents
Chemoembolization for Liver Cancer
Phase 2
Recruiting
Led By Carin Gonsalves, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 year
Awards & highlights
Study Summary
This trial is testing the effect of transarterial chemoembolization, which involves injecting a blocking agent and chemotherapy drug into the artery of the liver, in patients with uveal melanoma that has spread to the liver.
Who is the study for?
This trial is for adults with uveal melanoma that has spread to the liver. Participants must be able to consent, have good kidney function and physical health, a certain level of blood cells and albumin, and tumors detectable by imaging. They can't join if they're under 18, pregnant or breastfeeding, have had certain previous liver treatments or surgeries, uncontrolled other diseases like heart failure or hepatitis, severe bleeding tendencies or life-threatening allergies to specific drugs.Check my eligibility
What is being tested?
The study tests transarterial chemoembolization on liver metastases from uveal melanoma. It involves injecting carmustine (chemotherapy) combined with ethiodized oil and gelatin sponge directly into the liver artery to shrink or eliminate tumors.See study design
What are the potential side effects?
Potential side effects may include pain at the injection site, fever post-procedure (post-embolization syndrome), changes in liver function tests, fatigue due to chemotherapy drug carmustine as well as possible allergic reactions to any of the substances used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, which started in the eye, has spread to my liver.
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My tumor is less than 75% of my organ's size and at least one tumor is 10 mm or larger.
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I am fully active or can carry out light work.
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I do not have fluid buildup in my abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response to treatment
Disease control rate (DCR) including complete response + partial response + stable disease
Secondary outcome measures
Incidence of adverse events
Overall survival
Time to progression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (carmustine, ethiodized oil, gelatin sponge)Experimental Treatment4 Interventions
Patients undergo TACE by receiving an infusion of carmustine dissolved in ethiodized oil and an injection of gelatin sponge. Treatment repeats Q4W for bilobar disease or Q7W for unilobar disease in the absence of disease progression or unacceptable toxicity or until maximum clinical benefit is obtained.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carmustine
FDA approved
Transarterial Chemoembolization
2009
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,461 Total Patients Enrolled
Carin Gonsalves, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
598 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your albumin level is 3.0 grams per deciliter or higher.My brain metastases are stable for over 4 weeks after treatment.Your bilirubin level needs to be below 2.0 mg/ml, unless you have Gilbert's Syndrome, in which case a level below 3.0 mg/ml is allowed.My cancer, which started in the eye, has spread to my liver.I need treatment soon for cancer spread beyond the liver, but I can have radiation.I have had treatments targeting my liver.You have had a severe allergic reaction to iodine contrast or BCNU even after taking steroids beforehand.You have a blockage in the portal vein, or not enough alternative blood flow around the blockage, as shown by an MRI.Your white blood cell count is at least 1500 cells per cubic millimeter.I do not have uncontrolled high blood pressure, heart failure, or a recent heart attack.I don't have uncontrolled severe bleeding or active GI bleeding.I have hepatitis with liver enzyme levels more than 5 times the normal.I haven't had treatments through the artery for my liver cancer, but I may have had other types of liver treatments.You have another medical condition that doctors think may make you live less than six months.I have had surgery or a procedure on my bile ducts, but not gallbladder removal.My tumor is less than 75% of my organ's size and at least one tumor is 10 mm or larger.I am willing and able to give my consent for treatment.I am under 18 years old.Your serum creatinine level is less than or equal to 2.0 mg/dl.I am fully active or can carry out light work.You have a platelet count of 150,000 or more per cubic millimeter of blood.I do not have fluid buildup in my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carmustine, ethiodized oil, gelatin sponge)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what circumstances is Transarterial Chemoembolization usually recommended?
"Transarterial Chemoembolization is a useful treatment for hodgkin disease, hysterosalpingogram and ependymomas."
Answered by AI
How many participants are enrolled in this scientific trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is still seeking participants since its inception on September 27th of 2021 and final edit date of November 16th 2022. There are 28 positions available at a single facility."
Answered by AI
Is Transarterial Chemoembolization a secure procedure for individuals?
"The safety of transarterial chemoembolization was rated a 2 as this is a Phase 2 trial, meaning there are some early indications supporting its security yet no data confirming efficacy."
Answered by AI
Are there any vacancies for participants in this study?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical study which was created on September 27th 2021 is still open for recruitment. The research team aims to enroll 28 patients at 1 site before closing enrollment."
Answered by AI
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