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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given via infusion
Given via infusion
Undergo TACE
Given gelatin sponge via injection
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, United States
Best response to treatment
Response to treatment
Time frame: After the completion of cycle 2 of chemoembolization (1 cycle = 4 or 7 weeks)
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.
Time frame: Up to 2 years
Time to progression
Will be estimated by the Kaplan-Meier method.
Time frame: From the first chemoembolization to the time when progression of liver metastases is confirmed, assessed up to 2 years
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.
Time frame: From the first chemoembolization until death, assessed up to 2 years
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