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Sponsored by: |
Hana Biosciences, Inc |
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Information provided by: | Hana Biosciences, Inc |
ClinicalTrials.gov Identifier: | NCT00506142 |
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 30 patients will take part in this study.
Condition | Intervention | Phase |
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Metastatic Malignant Uveal Melanoma |
Drug: Marqibo® (vincristine sulfate liposomes injection) |
Phase II |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lucy Prasad | 650-228-5014 | lucy.prasad@hanabiosciences.com |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Elizabeth Seja 310-794-6892 | |
Principal Investigator: John Glaspy, MD | |
United States, Colorado | |
University of Colorado, Denver | Recruiting |
Denver, Colorado, United States, 80045 | |
Contact: Mary M. Cook 720-848-0624 | |
Principal Investigator: Rene Gonzalez, MD | |
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 |
Responsible Party: | Hana Biosciences, Inc. ( Michael Imperiale, MD, VP Clinical Research Operations ) |
Study ID Numbers: | HBS408 (formerly IST401) |
Study First Received: | July 23, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00506142 |
Health Authority: | United States: Food and Drug Administration |
Neuroectodermal Tumors Uveal melanoma Eye Neoplasms Intraocular melanoma Eye Diseases Nevus, Pigmented |
Neoplasms, Germ Cell and Embryonal Vincristine Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
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 |