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Delcath FOCUS Study for Metastatic Uveal Melanoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to find out if the Melphalan /HDS therapy is effective for people with uveal melanoma that has spread to the liver and to look at side effects of the therapy. We want to find out if the therapy can reduce the size of liver tumors.

What is the Condition Being Studied?

Uveal Melanoma

Who Can Participate in the Study?

Adults with uveal melanoma (started in the eye) that spread to the liver.

Age Group
Adults

What is Involved?

If you join the study, you will:
- Have a physical exam and other tests
- Imaging scans (CT scans and MRI scans)
- Receive the Melphalan/HDS therapy up to 6 times, once every 6-8 weeks with blood work every week
- Have liver scans every 10-14 weeks.

Study Details

Full Title
A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma
Principal Investigator
Surgical Oncologist
Protocol Number
IRB:PRO00069107
NCT:NCT02678572
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698