Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

Completed · Phase 2

Conditions studied: Metastatic Malignant Uveal Melanoma

In brief

Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously. The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied. Approximately 50 patients will take part in this study.

Key facts

Study ID

NCT00506142

Run by

Spectrum Pharmaceuticals, Inc

People needed

54

Starts

2007-11-01

Expected to finish

2014-12-01

Last updated by the study team

2019-12-11

Who can join

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

You may qualify if…

• Uveal melanoma with histologic or cytologic confirmation of metastatic disease.
• One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be >20 mm with conventional techniques or >10 mm with spiral CT scan. Bone lesions are not considered measurable.
• Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.
• Adequate liver, renal, and bone marrow function.
• Zubrod performance status of 0-2.
• Sign an informed consent form.

You may not qualify if…

• Major surgery within 4 weeks of enrollment.
• Advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".
• History of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
• Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause.
• Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of Colorado, Denver — Denver, Colorado, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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