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Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00506142
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : November 27, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Malignant Uveal Melanoma Drug: Marqibo® (vincristine sulfate liposomes injection) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
Study Start Date : November 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
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)

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.
Experimental: Cohort 2
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)

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506142


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80045
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
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Principal Investigator: Deborah Sanders, MD MD Anderson
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00506142    
Other Study ID Numbers: HBS408 (formerly IST401)
First Posted: July 25, 2007    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: December 11, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
 Neoplasms by Site
Eye Diseases
Uveal Diseases
Vincristine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action