Back to resultsSafety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Primary Purpose
Metastatic Malignant Uveal Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Marqibo® (vincristine sulfate liposomes injection)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Malignant Uveal Melanoma
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.
Sites / Locations
- University of California, Los Angeles
- University of Colorado, Denver
- Thomas Jefferson University
- University of Texas M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm 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.
Outcomes
Primary Outcome Measures
Disease Control Rate
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Secondary Outcome Measures
Full Information
NCT ID
NCT00506142
First Posted
July 23, 2007
Last Updated
November 27, 2019
Sponsor
Spectrum Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00506142
Brief Title
Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Official Title
A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Uveal Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
Intervention Type
Drug
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Disease Control Rate
Description
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Sanders, MD
Organizational Affiliation
MD Anderson
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Colorado, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20978276
Citation
Bedikian AY, Silverman JA, Papadopoulos NE, Kim KB, Hagey AE, Vardeleon A, Hwu WJ, Homsi J, Davies M, Hwu P. Pharmacokinetics and safety of Marqibo (vincristine sulfate liposomes injection) in cancer patients with impaired liver function. J Clin Pharmacol. 2011 Aug;51(8):1205-12. doi: 10.1177/0091270010381499. Epub 2010 Oct 26.
Results Reference
derived
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Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
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