Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

Conditions
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Metastatic Malignant Uveal Melanoma

Intervention / Treatment
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* Drug: Marqibo® (vincristine sulfate liposomes injection)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Patients were enrolled into the study in two cohorts. After completion of enrollment in Cohort 1, enrollment in Cohort 2 has commenced.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. | Drug: Marqibo® (vincristine sulfate liposomes injection)<br>* Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.<br>|
| Experimental: Cohort 2<br>Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | Drug: Marqibo® (vincristine sulfate liposomes injection)<br>* Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate | Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) | 1 year |