A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular Melanoma (NCT00062933) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular Melanoma
United States40 participantsStarted 2003-06
Plain-language summary
Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver. A tumor in the liver, because of its size or location, sometimes cannot be removed with surgery.
The purpose of this study is to determine whether chemotherapy delivered only to the liver, called isolated hepatic perfusion (IHP), followed by systemic (to the whole body) chemotherapy improves the ability to treat cancer.
Study participants must be 18 years or older and have ocular melanoma that has spread to the liver. Before enrolling in the study, they will undergo the following evaluations: a physical exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest, abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.
The study includes a 15-minute quality-of-life questionnaire. Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress.
A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans. When this happens, the participant is ineligible to continue in the study, since an important part of the treatment is given only to the liver.
If the laparotomy reveals that the participant is eligible for the remainder of the study, the participant will receive IHP treatment during the surgery. Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver. This creates a separate blood supply for the liver alone. Heated chemotherapy is then given into the liver blood supply for one hour, while being carefully kept out of the rest of the body.
After recovering from the surgery, eligible participants will receive a systemic chemotherapy called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.
Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Histologically or cytologically proven measurable metastatic ocular melanoma confined to the liver. Patients with limited sites of extra-hepatic disease and who have dominant life-limiting disease in liver will be considered eligible if the extra-hepatic sites can be treated with local ablative measures such as resection or external beam radiation therapy. Patients with limited extra-hepatic disease will undergo IHP and treatment of extra-hepatic disease in a sequence determined by the clinical presentation but all patients will have had all disease treated prior to initiating temozolomide therapy.
Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for 28 days prior to the liver perfusion and must have recovered from all side effects except those outlined in appendix III.
Patients must have an ECOG performance standard of 0,1 or 2 prior to on-study and on the day prior to treatment with IHP.
Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT equal to 2 seconds of the upper normal limit AST/ALT less than or equal to 10 times ULN.
Patients must be 18 years of age or greater and must be greater than 30 kg, because of reason outlined in Section 6.2.
Patients must have a platelet count greater than 75,000, a HCT greater than 27.0, an ANC greater than or equal to 1,500/ul, and a creatinine less than or equal to 1.5 mg/dL unless the measured creatinine clearance i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.