Open-Label Study of Melphalan/HDS for Patients with Liver-Dominant Eye Melanoma

Sponsor: Delcath Systems Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05022901

This study is testing a treatment called Melphalan/HDS for patients with eye melanoma that has spread mainly to the liver. Participants will receive up to 6 treatments to evaluate the safety and effects of this therapy.

Patient Parameters

Parameter	Options

Program Overview

This clinical trial is designed to test the safety and effects of a treatment called Melphalan/HDS in patients with eye melanoma that has primarily spread to the liver. Participants will receive up to 6 treatments and will be monitored for their response to the therapy.

Description

The study consists of three phases:

Screening/Baseline Phase: Before joining the study, participants will undergo various tests within 28 days to check their eligibility. These tests include medical history, physical exams, heart and liver function tests, and imaging scans to assess the cancer's status.
Treatment Phase: Eligible participants will start treatment within 14 days after being confirmed eligible. They will receive Melphalan/HDS every 6 weeks for up to 6 cycles. The treatment may be delayed by up to 2 weeks if needed for recovery. Tumor response will be checked every 12 weeks. If the cancer progresses or if recovery from side effects takes too long, treatment will stop. An end-of-treatment visit will occur 6 to 8 weeks after the last treatment.
Follow-up Phase: After completing treatment, participants will have regular check-ups every 12 weeks to monitor the cancer's status. If the cancer progresses, follow-up will continue by phone every 3 months to check on the participant's health.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Must weigh at least 35 kg.
Have eye melanoma that has spread to the liver, with 50% or less of the liver affected.
Cancer in the liver must be measurable by CT or MRI scans.
Limited cancer outside the liver is acceptable if it can be treated.
Must not have had certain cancer treatments within 30 days before starting the study.
Must have good liver function and blood counts.
Women of childbearing age must have a negative pregnancy test and agree to use contraception.
Must provide informed consent to participate.

Exclusion Criteria

Severe liver disease or heart conditions.
Significant lung disease that prevents anesthesia use.
Women who cannot avoid menstruation during treatment.
Pregnant or breastfeeding women.
Taking certain medications that suppress the immune system.
Active infections or severe allergies to study drugs.
History of bleeding disorders or certain surgeries.
Other active cancers or recent investigational treatments.

Locations

FACILITY	ZIP	CITY	STATE
Stanford Cancer Institute	94304	Palo Alto	California
Moffitt Cancer Center	12902	Tampa	Florida
Duke University Medical Center	27710	Durham	North Carolina
The Ohio State University	43221	Columbus	Ohio
University of Tennessee Health Science Center	38163	Memphis	Tennessee

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