Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04728633
Other study ID # 20P.1076
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 27, 2021
Est. completion date March 31, 2026

Study information

Verified date September 2023
Source Thomas Jefferson University
Contact Carin Gonsalves, MD
Phone 215-955-6385
Email Carin.Gonsalves@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date March 31, 2026
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Carmustine
Given via infusion
Ethiodized Oil
Given via infusion
Procedure:
Transarterial Chemoembolization
Undergo TACE
Other:
Medical Device Usage and Evaluation
Given gelatin sponge via injection

Locations

Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best response to treatment Response to treatment After the completion of cycle 2 of chemoembolization (1 cycle = 4 or 7 weeks)
Primary Disease control rate (DCR) including complete response + partial response + stable disease All estimates of rates (e.g., DCR) will be presented with corresponding confidence intervals. For DCR, the method of Atkinson and Brown will be used to allow for the two-stage design using the criteria adapted from the international criteria proposed by Response Evaluation Criteria in Solid Tumors 1.03. Up to 2 year
Secondary Time to progression Will be estimated by the Kaplan-Meier method. From the first chemoembolization to the time when progression of liver metastases is confirmed, assessed up to 2 years
Secondary Overall survival Will be estimated by the Kaplan-Meier method. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer unrelated. From the first chemoembolization until death, assessed up to 2 years
Secondary Incidence of adverse events Safety will be assessed and the toxicity of the treatment will be monitored using the National Cancer Institute Common Toxicity Criteria version 5. All estimates of rates (e.g., toxicity) will be presented with corresponding confidence intervals. Up to 30 days after the last day of study participation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03068624 - Autologous CD8+ SLC45A2-Specific T Lymphocytes With Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma Phase 1
Recruiting NCT05987332 - IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma Phase 2/Phase 3
Completed NCT01551459 - A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma Phase 2
Active, not recruiting NCT00986661 - A Study to Assess PV-10 Chemoablation of Cancer of the Liver Phase 1
Completed NCT01585194 - Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma Phase 2
Withdrawn NCT01328106 - Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma Phase 2
Recruiting NCT05075993 - Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors Phase 1
Active, not recruiting NCT04552223 - Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma Phase 2
Recruiting NCT05607095 - Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma Phase 1
Active, not recruiting NCT01587352 - Vorinostat in Treating Patients With Metastatic Melanoma of the Eye Phase 2
Active, not recruiting NCT03472586 - Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver Phase 2
Active, not recruiting NCT03025256 - Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease Phase 1
Terminated NCT04879017 - FHD-286 in Subjects With Metastatic Uveal Melanoma Phase 1
Terminated NCT01814046 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma Phase 2
Recruiting NCT03947385 - Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions Phase 1/Phase 2
Active, not recruiting NCT03865212 - Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma Phase 1
Active, not recruiting NCT05022901 - An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma Phase 3
Recruiting NCT05282901 - Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME) Phase 2
Recruiting NCT05415072 - A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas Phase 1/Phase 2
Active, not recruiting NCT04720417 - Defactinib and VS-6766 for the Treatment of Patients With Metastatic Uveal Melanoma Phase 2