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Melphalan/HDS for Ocular Melanoma
Study Summary
This trial tests a treatment (Melphalan/HDS) with up to 6 doses, to see how safe and effective it is.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 30 Patients • NCT01877837Trial Design
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- I have severe liver disease with symptoms like portal hypertension.You must weigh at least 35 kilograms because of the way the treatment is given through a catheter in the leg.Half or less of my liver is affected by eye melanoma.My liver disease can be seen on a CT or MRI scan.My eligibility scans were done within the last 28 days.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.I am a woman who can have children and cannot stop my periods during treatment.I agree to use effective birth control during and 6 months after the study.I have varices or an active ulcer that could bleed.I am 18 years old or older.I am not pregnant or breastfeeding.I have brain metastases or lesions at risk of bleeding.My diabetes or thyroid condition is not under control.I do not have an active bacterial infection with symptoms like fever or fatigue.I do not have an active infection, including Hepatitis B or C, or I am only HBc positive/HBsAg positive but DNA negative.You have a strong allergic reaction to iodine contrast that cannot be controlled with medication before the procedure.I am fully active or restricted in physically strenuous activity but can do light work.I have had a gastrinoma and may need a special scan if I've had liver or major blood vessel surgery.I have had a Whipple's procedure in the past.My side effects from previous treatments are mild, except for hair loss.My liver functions within normal limits according to my blood tests.I haven't had cancer treatments in the last 30 days and have recovered from any side effects.My life-threatening cancer is primarily in my liver, though it may have spread slightly beyond.I have a serious heart condition that needs evaluation before any surgery.I finished my PD-1 or CTLA-4 inhibitor therapy at least 8 weeks ago.I do not have a history of bleeding disorders or brain conditions that increase my risk of bleeding.I have a lung condition that prevents me from having general anesthesia.You are allergic to melphalan or any parts of the Melphalan/HDS system.You are allergic to latex.You have had a bad reaction to heparin or have a condition called heparin-induced thrombocytopenia.I am on immunosuppressive drugs, but my daily corticosteroid dose is 10 mg or less.I cannot stop my long-term blood thinner medication.I am being treated for cancer other than ocular melanoma, or I am not yet cancer-free.Your AST and ALT levels in the blood must be less than 2.5 times the upper limit of normal.My blood and kidney tests meet the required levels for the trial.
- Group 1: Melphalan/HDS
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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