Marqibo® (vincristine sulfate liposomes injection)
DrugCohort 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.
Completed
NCT Number: NCT00506142
Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
University of California, Los Angeles, Los Angeles, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Disease Control Rate
Time frame: 1 year
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Sponsors and collaborators
Lead sponsor
Spectrum Pharmaceuticals, Inc
Industry
Registry information
Official study title
A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
Important dates
- Study start
- 2007
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jul 25, 2007
- Registry last updated
- Dec 11, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.