Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Condition: Metastatic Malignant Uveal Melanoma
MeSH terms: Melanoma; Uveal Neoplasms
Intervention: Marqibo® (vincristine sulfate liposomes injection)
Intervention description: 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.
Intervention MeSH terms: Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention 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)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.