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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) National Comprehensive Cancer Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00738361 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.
Condition | Intervention | Phase |
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Intraocular Melanoma |
Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study Of Weekly Infusion Nab-Paclitaxel (Paclitaxel Protein-Bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma |
Estimated Enrollment: | 25 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed uveal melanoma
Brain metastasis allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 months since prior chemoembolization or embolization of the liver
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Thomas E. Olencki, DO 866-627-7616 |
Principal Investigator: | Thomas E. Olencki, DO | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study Chair: | Thomas E. Olencki, DO | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Thomas E. Olencki ) |
Study ID Numbers: | CDR0000612312, OSU-08076, OSU-2008C0075, NCCN-AO7 |
Study First Received: | August 19, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00738361 |
Health Authority: | Unspecified |
ciliary body and choroid melanoma, medium/large size iris melanoma metastatic intraocular melanoma recurrent intraocular melanoma extraocular extension melanoma |
Ocular melanoma Eye Neoplasms Eye Diseases Recurrence Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors |
Uveal melanoma Paclitaxel Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Nevus |
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 |