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Alkylating agents

Percutaneous Hepatic Perfusion for Eye Melanoma with Liver Metastases (FOCUS Trial)

Phase 3
Waitlist Available
Led By Jonathan Zager, MD
Research Sponsored by Delcath Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System)
Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking antibody such as ipilimumab should wait 8 weeks before Melphalan/HDS treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up orr will be assessed every 10-14 weeks from the start of 1st treatment and continues until the earlier of either when there is evidence of disease progression or 1 year from 1st treatment.
Awards & highlights

FOCUS Trial Summary

This trial will study the safety and efficacy of Melphalan/HDS in patients with melanoma that has spread from the eye to the liver. Patients will be treated up to six times and followed until death.

Who is the study for?
Adults with ocular melanoma that has spread to the liver can join this trial if they weigh at least 35 kg, have not had certain cancer treatments in the last month, and are generally healthy. They must not be pregnant or breastfeeding and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Melphalan/HDS treatment on patients with eye melanoma that has moved to the liver. It aims to see how safe it is and how it affects patient survival and cancer progression.See study design
What are the potential side effects?
Possible side effects of Melphalan/HDS may include reactions related to infusion, changes in blood counts, fatigue, nausea, liver issues, and increased risk of infection.

FOCUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You need to weigh at least 35 kilograms to ensure that a medical device can be used safely.
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If you have been taking certain immunotherapy medications, you need to wait 8 weeks before starting Melphalan/HDS treatment.
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You are 18 years old or older.
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If the cancer has spread outside the liver, it can be treated with surgery or radiation. If the cancer has spread and there is no treatment plan, you cannot participate.

FOCUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~orr will be assessed every 10-14 weeks from the start of 1st treatment and continues until the earlier of either when there is evidence of disease progression or 1 year from 1st treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and orr will be assessed every 10-14 weeks from the start of 1st treatment and continues until the earlier of either when there is evidence of disease progression or 1 year from 1st treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) as determined by Independent Central Review Committee
Secondary outcome measures
Disease Control Rate (DCR) determined by Independent Central Review Committee
Duration of Response (DOR) as determined by Independent Central Review Committee
Overall Survival
+1 more
Other outcome measures
Exploratory Analysis for Demographics
Exploratory Analysis of performance status
Exploratory analysis for the amount of liver involvement
+7 more

FOCUS Trial Design

1Treatment groups
Experimental Treatment
Group I: Melphalan/HDSExperimental Treatment1 Intervention
3 mg/kg ideal body weight of melphalan for infusion administered directly to the liver via percutaneous hepatic perfusion (PHP) over 30 minutes followed by a 30 minute washout. Treatment cycles are to be repeated every 6-8 weeks until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan/HDS
2016
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

Delcath Systems Inc.Lead Sponsor
8 Previous Clinical Trials
691 Total Patients Enrolled
IQVIA BiotechIndustry Sponsor
18 Previous Clinical Trials
4,806 Total Patients Enrolled
Jonathan Zager, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials

Media Library

Melphalan/HDS (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02678572 — Phase 3
Eye Melanoma Research Study Groups: Melphalan/HDS
Eye Melanoma Clinical Trial 2023: Melphalan/HDS Highlights & Side Effects. Trial Name: NCT02678572 — Phase 3
Melphalan/HDS (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02678572 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to accept people into this trial?

"This study is not recruiting patients at this present time. The clinical trial was originally posted on February 1st, 2016 and was most recently updated on March 23rd, 2022. However, there are 781 other studies actively recruiting patients with ocular melanoma and 119 trials for Melphalan/HDS that are currently looking for participants."

Answered by AI

In how many different medical clinics is this medical study being run today?

"University of Chicago in Chicago, Illinois, Stanford University in Palo Alto, California, and Emory University in Atlanta, Georgia are all managing this study out of their respective locations. Additionally, there are 10 other sites running this same clinical trial."

Answered by AI

What are the approved indications for Melphalan/HDS?

"Melphalan/HDS can be an effective treatment for multiple myeloma, hematopoietic stem cells, and carcinoma."

Answered by AI

Are there any similar past studies to the Melphalan/HDS clinical trial?

"The first Melphalan/HDS clinical trial was completed in 1997 at City of Hope Comprehensive Cancer Center. As of now, there has been a total of 220 completed trials with 119 active studies recruiting patients. Many of these research facilities are based in Chicago, Illinois."

Answered by AI

How many people are included in this test group?

"This study is not recruiting patients at the moment. The trial was originally posted on February 1st, 2016 and updated more recently on March 23rd, 2022. There are 781 other trials for ocular melanoma that are currently looking for participants as well as 119 studies involving Melphalan/HDS."

Answered by AI

What is the FDA's current stance on Melphalan/HDS?

"Melphalan/HDS is classified as a Phase 3 medication, meaning that there have been multiple rounds of testing affirming its efficacy and safety."

Answered by AI
~11 spots leftby Mar 2025