A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular Melanoma

Completed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID: NCT00062933
Run by: National Cancer Institute (NCI)
People needed: 40
Starts: 2003-06-01
Expected to finish: 2008-03-01
Last updated by the study team: 2012-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Pregnant patients and nursing mothers will be excluded due to the unknown effects of melphalan on the fetus or newborn.
Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.
Patients with active systemic infections are not eligible.
Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded.
Patients with a history of congestive heart failure with an LVEF less than 40% will be excluded.
Patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be excluded.
Patients with a history or diagnosis of veno-occlusive disease (VOD) will be excluded.
Patients with chronic active hepatitis based on a positive serology test for surface antigen B or C will be excluded if there is evidence of cirrhosis on pathology. If no pathology specimen exists then evidence for cirrhosis will be determined based on radiological studies and physical examination. If there are no indications of it then the patient will be registered on study and a biopsy will be obtained at the time of laparotomy for IHP with the expectation that occult clinically significant cirrhosis is very unlikely. If cirrhosis is pathologically confirmed the patient will not undergo treastment and be taken off study. Patients with radiographic or other signs of cirrhosis will undergo percutaneous biopsy prior to registration.
Patients with a prior hypersensitivity reaction to melphalan, dacarbazine, or temozolomide will be ineligible for study.

Where it is running

National Cancer Institute (NCI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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