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Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

This study is currently recruiting participants.
Verified by Hana Biosciences, Inc, July 2008

Sponsored by: Hana Biosciences, Inc
Information provided by: Hana Biosciences, Inc
ClinicalTrials.gov Identifier: NCT00506142
  Purpose

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.

Up to 30 patients will take part in this study.


Condition Intervention Phase
Metastatic Malignant Uveal Melanoma
Drug: Marqibo® (vincristine sulfate liposomes injection)
Phase II

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Vincristine sulfate    Vincristine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:   A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma

Further study details as provided by Hana Biosciences, Inc:

Primary Outcome Measures:
  • Overall response rate. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   November 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Marqibo® (vincristine sulfate liposomes injection)
    Subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  • Previously untreated or may have received one prior systemic chemotherapy. Prior treatment with immunotherapy or vaccine is allowed provided there is documentation of disease progression. Prior treatment with hepatic arterial chemotherapy infusion/perfusion or chemoembolization of liver metastasis is allowed as long as there is extrahepatic disease or progression of the liver metastasis after regional therapy.
  • Adequate liver, renal, and bone marrow function.
  • Zubrod performance status of 0-2.
  • Age > 18 years old.
  • Sign an informed consent form.

Exclusion Criteria:

  • Radiotherapy, chemotherapy, immunotherapy, vaccine treatment and/or alternative anticancer treatments (including investigational drugs) within 3 weeks prior to study enrollment.
  • Hepatic chemoembolization within 4 weeks prior to study enrollment.
  • 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 3 or greater sensory, motor 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506142

Contacts
Contact: Lucy Prasad     650-228-5014     lucy.prasad@hanabiosciences.com    

Locations
United States, Pennsylvania
Thomas Jefferson University     Recruiting
      Philadelphia, Pennsylvania, United States, 19107
      Contact: Mary Ann Laudadio     215-955-9980     mary.ann.laudadio@jefferson.edu    
      Principal Investigator: Takami Sato, MD            
United States, Texas
University of Texas M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Agop Bedikian, MD            

Sponsors and Collaborators
Hana Biosciences, Inc
  More Information


Responsible Party:   Hana Biosciences, Inc. ( Michael Imperiale, MD, VP Clinical Research Operations )
Study ID Numbers:   HBS408 (formerly IST401)
First Received:   July 23, 2007
Last Updated:   July 28, 2008
ClinicalTrials.gov Identifier:   NCT00506142
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Uveal melanoma
Eye Neoplasms
Intraocular melanoma
Eye Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Vincristine
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 22, 2008




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