Overseen ByCarin Gonsalves, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Thomas Jefferson University
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial studies a treatment that injects chemotherapy and blocking agents into the liver's blood vessels to target tumors in patients with eye cancer that has spread to the liver. The goal is to cut off the tumor's blood supply and apply chemotherapy directly, helping to shrink or eliminate the tumors. This method delivers highly concentrated drugs to the tumor and stops blood flow to it.
What safety data is available for chemoembolization in liver cancer treatment?Safety data for chemoembolization, specifically Transarterial Chemoembolization (TACE), shows that it is generally a safe procedure with some adverse events. Studies indicate that adverse events can include nausea, vomiting, and moderate transient epigastric pain. Severe adverse events like thrombocytopenia are rare. Comparisons between conventional TACE and drug-eluting bead TACE (DEB-TACE) suggest differences in adverse event profiles, but both are considered safe. Biliary complications are rare but possible. Overall, TACE is a safe and effective palliative treatment for unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocellular carcinoma (ICC).367813
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, immune check-point inhibitors are not allowed while on the study, and certain conditions like active viral or autoimmune hepatitis requiring treatment may affect eligibility. It's best to discuss your specific medications with the trial team.
Is the treatment Transarterial Chemoembolization (TACE) with the drug Carmustine promising for liver cancer?Transarterial Chemoembolization (TACE) is a treatment often used for liver cancer, especially in certain stages. It is considered a standard procedure and is sometimes used in place of other treatments. However, the research does not specifically mention Carmustine, so it's unclear if TACE with Carmustine is promising based on the provided information.2491011
What data supports the idea that Chemoembolization for Liver Cancer is an effective treatment?The available research shows that transarterial chemoembolization (TACE) is associated with better survival for patients with a specific type of liver cancer called BCLC-stage B hepatocellular carcinoma. However, the evidence is mixed when comparing TACE to other treatments like liver resection or radiofrequency ablation. Some studies suggest TACE is beneficial, while others find it controversial or unclear. Overall, TACE seems to help certain patients, but its effectiveness can vary depending on the patient's condition and the stage of cancer.1591112
Eligibility Criteria
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.Inclusion Criteria
My cancer, which started in the eye, has spread to my liver.
My tumor is less than 75% of my organ's size and at least one tumor is 10 mm or larger.
I am fully active or can carry out light work.
I do not have fluid buildup in my abdomen.
Exclusion Criteria
I have had treatments targeting my liver.
I do not have uncontrolled high blood pressure, heart failure, or a recent heart attack.
I have hepatitis with liver enzyme levels more than 5 times the normal.
I have had surgery or a procedure on my bile ducts, but not gallbladder removal.
I am under 18 years old.
Participant Groups
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.
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.
Carmustine is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as BiCNU for:
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
πͺπΊ Approved in European Union as Carmubris for:
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
π¨π¦ Approved in Canada as BCNU for:
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sidney Kimmel Cancer Center at Thomas Jefferson UniveristyPhiladelphia, PA
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
References
Treatment outcomes for hepatocellular carcinoma using chemoembolization in combination with other therapies. [2014]Although transarterial chemoembolization (TACE) improves survival in patients with hepatocellular carcinoma (HCC), it is not known if TACE combined with other treatments is beneficial.
Treatment outcome of patients with liver-only metastases from breast cancer after mastectomy: a retrospective analysis. [2021]To evaluate the efficiency of combined treatment of transcatheter arterial chemoembolization (TACE) and systemic chemotherapy (SC) for liver-only metastases from breast cancer after mastectomy.
Liver/biliary injuries following chemoembolisation of endocrine tumours and hepatocellular carcinoma: lipiodol vs. drug-eluting beads. [2022]Transarterial chemoembolisation (TACE) is usually performed by injecting an emulsion of a drug and iodised oil. Drug-eluting beads (DEBs) have undeniable pharmacological advantages by offering simultaneous embolisation and sustained release of the drug to the tumour. No data are currently available on liver/biliary injury following DEB-TACE. This study describes and compares liver/biliary injuries encountered with TACE in tumours developed in cirrhotic (hepatocellular carcinoma (HCC)) and non-cirrhotic (endocrine tumours (NETs)) livers.
Prospective evaluation of transcatheter arterial chemoembolization (TACE) with multiple anti-cancer drugs (epirubicin, cisplatin, mitomycin c, 5-fluorouracil) compared with TACE with epirubicin for treatment of hepatocellular carcinoma. [2022]To compare the efficacy of transcatheter arterial chemoembolization (TACE) using multiple anticancer drugs (epirubicin, cisplatin, mitomycin C, and 5-furuorouracil: Multi group) with TACE using epirubicin (EP group) for hepatocellular carcinoma (HCC).
Safety and efficacy of transcatheter arterial chemoemboliazation in the real-life management of unresectable hepatocellular carcinoma. [2021]Trans-arterial chemoembolization (TACE) is associated with better survival in BCLC-stage B patients with hepatocellular carcinoma (HCC) and Child-Pugh A whereas in Child-Pugh B there is no definite evidence of benefit.
Biliary complications of arterial chemoembolization of hepatocellular carcinoma. [2015]Transarterial chemoembolization (TACE) is the most frequently used palliative therapy for unresectable hepatocellular carcinoma (HCC). It is a safe and effective procedure with few major and minor complications. Rarely, biliary complications are also encountered following TACE. The goal of our study was to investigate the incidence and the presentation of biliary complications following TACE in patients with HCC.
Treatment of Huge Hepatocellular Carcinoma Using Cinobufacini Injection in Transarterial Chemoembolization: A Retrospective Study. [2020]The aim of this study is to examine the safety and efficacy of Cinobufacini injection in transarterial chemoembolization (TACE) for treatment of huge hepatocellular carcinoma (HCC). Clinical data of 56 consecutive patients with HCC larger than 10 cm who had been treated with TACE between December 2010 and August 2014 were retrospectively analyzed. Among these patients, 31 belonged to the Cinobufacini group and 25 belonged to the epirubicin group. The clinical efficacy, survival time, and adverse events in patients in the two groups were compared. The objective response rate in the Cinobufacini group was significantly higher than that in the epirubicin group (53.6% versus 23.1%, P = 0.022). The median survival time (10.6 versus 14.1 months, Ο (2) = 0.092, P = 0.762) and the median time to progression (4.9 versus 5.7 months, Ο (2) = 0.097, P = 0.756) were similar between the groups. The incidence rate of adverse events was lower in the Cinobufacini group than in the epirubicin group (P
Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy. [2022]BACKGROUND The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). MATERIAL AND METHODS This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. RESULTS Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). CONCLUSIONS The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime.
Predictors of Micrometastases in Patients with Barcelona Clinic Liver Cancer Classification B Hepatocellular Carcinoma. [2018]Transarterial chemoembolization (TACE) is indicated for Barcelona Clinic Liver Cancer (BCLC) B hepatocellular carcinoma (HCC). Whether TACE provides any long-term survival benefits remains unclear. We aimed to investigate micrometastases predictors with which to identify patients who would benefit from surgical resection (SR).
Transarterial chemoembolisation for breast cancer with liver metastasis: A systematic review. [2018]There is limited data on the impact of transarterial chemoembolisation (TACE) on survival in patients of breast cancer with liver metastasis (BCLM).
Transarterial chemoembolization as a substitute to radiofrequency ablation for treating Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma. [2022]Transarterial chemoembolization (TACE) is the standard procedure for treating Barcelona clinic liver cancer (BCLC) stage B hepatocellular carcinoma (HCC). However, it is often carried out in the treatment of BCLC stage 0/A HCC for various reasons. This study aimed to elucidate the prognosis for BCLC stage 0/A HCC patients treated with TACE or with radiofrequency ablation (RFA).
Liver resection versus transarterial chemoembolization for the initial treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma. [2019]Current evidence supporting the efficacy of transarterial chemoembolization (TACE) in Barcelona Clinic Liver Cancer (BCLC)-B hepatocellular carcinoma (HCC) is controversial. The aim of this systematic review was to compare the benefits of liver resection (LR) versus TACE in BCLC-B HCC.
A Comparison of Adverse Events Among Radiofrequency Ablation, Conventional Transarterial Chemoembolization (TACE) and Drug-Eluting Bead TACE in Treating Hepatocellular Carcinoma Patients. [2022]There has been very limited investigation regarding the comparison of adverse events (AEs) among radiofrequency ablation (RFA), conventional transarterial chemoembolization (cTACE), and drug-eluting bead TACE (DEB-TACE) in treating HCC patients; therefore, the present study aimed to resolve this issue.