Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 6:49 PM
Study NCT ID:
NCT04728633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2021-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Chemoembolization of Uveal Melanoma Hepatic Metastases Using 300mg of BCNU Dissolved in Lipiodol® Followed by Gelfoam® Embolization
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Steroid taper will begin the day of patient discharge. After completion of study treatment, patients are followed up at 30 days, and then every 2 months for up to 2 years.
After 3 years from first treatment, follow-up scans may occur every 16-20 weeks and labs every other month.
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.
Steroid taper will begin the day of patient discharge. After completion of study treatment, patients are followed up at 30 days, and then every 2 months for up to 2 years.
After 3 years from first treatment, follow-up scans may occur every 16-20 weeks and labs every other month.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 15505 | OTHER | JeffTrial Number | View |