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Alkylating agents

Melphalan/HDS for Ocular Melanoma

Phase 3
Waitlist Available
Research Sponsored by Delcath Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ≥ 18 years of age
50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 (+/-2) weeks until progression, for up to 104 weeks
Awards & highlights

Study Summary

This trial tests a treatment (Melphalan/HDS) with up to 6 doses, to see how safe and effective it is.

Who is the study for?
Adults over 18 with ocular melanoma in the liver, weighing at least 35 kg, and not treated for cancer within the last month. They must have good liver function and overall health (ECOG PS of 0-1), no severe heart or lung conditions, no allergies to melphalan or latex, and not be pregnant. Participants should agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing a treatment called Melphalan/HDS for patients with ocular melanoma that has spread mainly to the liver. Patients will receive up to six treatments of Melphalan administered through a Hepatic Delivery System designed to target the liver directly.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion such as nausea and fatigue, allergic responses if sensitive to melphalan or other components in HDS system, potential bleeding risks due to anti-coagulation during treatment, and general anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Half or less of my liver is affected by eye melanoma.
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My liver disease can be seen on a CT or MRI scan.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver functions within normal limits according to my blood tests.
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My life-threatening cancer is primarily in my liver, though it may have spread slightly beyond.
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My eligibility scans were done within the last 28 days.
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I haven't had cancer treatments in the last 30 days and have recovered from any side effects.
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I finished my PD-1 or CTLA-4 inhibitor therapy at least 8 weeks ago.
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My blood and kidney tests meet the required levels for the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 (+/-2) weeks until progression, for up to 104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 (+/-2) weeks until progression, for up to 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Efficacy (ORR)
Efficacy (OS)
Efficacy (PFS)
+1 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: Melphalan/HDSExperimental Treatment1 Intervention
Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW). Melphalan/HDS treatment will be administered every 6 weeks for a total of 6 cycles with an acceptable delay of another 2 weeks before the next planned treatment to allow for recovery of melphalan-related toxicity, if needed.

Find a Location

Who is running the clinical trial?

Delcath Systems Inc.Lead Sponsor
8 Previous Clinical Trials
763 Total Patients Enrolled

Media Library

Melphalan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05022901 — Phase 3
Uveal Melanoma Research Study Groups: Melphalan/HDS
Uveal Melanoma Clinical Trial 2023: Melphalan Highlights & Side Effects. Trial Name: NCT05022901 — Phase 3
Melphalan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022901 — Phase 3

Frequently Asked Questions

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

Is participation in this research experiment still available?

"According to clinicaltrials.gov, this is an ongoing medical trial that was originally posted on June 10th 2022 and recently amended on April 3rd 2023; thus, the researchers are still searching for suitable candidates."

Answered by AI

Has the Melphalan/HDS combination been given the green light by regulatory agencies?

"According to our assessment, Melphalan/HDS can be deemed safe due its Phase 3 status, which suggests that there is evidence of efficacy and multiple checkups confirming safety."

Answered by AI

What is the total enrollment number for this research project?

"The sponsor of this trial, Delcath Systems Inc., needs 30 individuals that meet the criteria to progress with their study. This will be carried out across multiple sites such as Duke University Medical Center in Durham and Moffitt Cancer Center in Tampa."

Answered by AI
~11 spots leftby Mar 2025