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Percutaneous Hepatic Perfusion for Eye Melanoma with Liver Metastases (FOCUS Trial)
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.
FOCUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFOCUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FOCUS Trial Design
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Who is running the clinical trial?
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- You have had a severe allergic reaction to iodine contrast that couldn't be controlled with antihistamines and steroids.You have large varicose veins in your esophagus or stomach, or an active stomach ulcer.You need to weigh at least 35 kilograms to ensure that a medical device can be used safely.You have had a Whipple's procedure in the past.You have had a bad reaction to melphalan or any part of the Melphalan/HDS system in the past.You have severe liver disease or signs of high blood pressure in the liver.You have heart problems that are not stable and may be risky if you need general anesthesia.You have a serious lung disease that makes it unsafe to use general anesthesia.You are allergic to latex.You have brain metastases or other risky brain lesions.You have a current infection in your liver, such as Hepatitis B or Hepatitis C. However, if you have a certain type of Hepatitis B antibody, you may still be eligible.You have uncontrolled diabetes, underactive thyroid, or overactive thyroid.You have not fully recovered from the side effects of your previous treatment. Some side effects, like hair loss, are okay if they are not severe.Your liver function tests should show normal levels of bilirubin and prothrombin time, and the levels of AST and ALT should not be too high.You need to have enough platelets, hemoglobin, white blood cells, and neutrophils in your blood, and your kidney function should be normal.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.You are not taking strong medications that lower your immune system, except for small doses of oral corticosteroids.You cannot stop taking your blood thinning medication for a short time.Your liver disease can be seen and measured using a CT scan or MRI.If you have been taking certain immunotherapy medications, you need to wait 8 weeks before starting Melphalan/HDS treatment.Women who can have children and have had a period in the past year, and cannot take medication to stop their periods during the study.You have a bacterial infection with symptoms like feeling sick, fever, and high white blood cell count. You cannot join the study until you finish the right treatment for the infection.You have had a bad reaction to heparin in the past or have a condition called heparin-induced thrombocytopenia.You have a history of bleeding disorders or evidence of brain abnormalities that could make taking blood thinners risky for you.You have a history of certain liver conditions or blood flow issues in the liver.You have any type of cancer other than ocular melanoma and you are currently receiving treatment or have not been declared cancer-free.You are 18 years old or older.Less than half of your liver has been affected by confirmed eye melanoma spread.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.
- Group 1: Melphalan/HDS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
What are the approved indications for Melphalan/HDS?
"Melphalan/HDS can be an effective treatment for multiple myeloma, hematopoietic stem cells, and carcinoma."
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."
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."
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."
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