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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00861913 |
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects of pazopanib and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: pazopanib hydrochloride Genetic: DNA analysis Genetic: gene expression analysis Genetic: mutation analysis Other: laboratory biomarker analysis Other: pharmacogenomic studies Other: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Pazopanib (GW786034) in Pre-Treated and Untreated Metastatic Melanoma Patients |
Estimated Enrollment: | 37 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue biopsy at baseline and blood sample collection at baseline and on days 14, 28, and 42 for research studies. Tumor tissue samples are analyzed by DNA sequencing, ELISA, western blotting, and immunoperoxidase staining. Blood samples are analyzed for pharmacodynamics, pharmacokinetics, and pharmacogenetics by high-performance liquid chromatography with tandem mass spectrometry.
After completion of study treatment, patients are followed periodically for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable malignant melanoma
Measurable disease with ≥ 1 lesion whose longest diameter can be measured as ≥ 2.0 cm by CT or MRI scans or ≥ 1.0 cm by spiral CT scan
PATIENT CHARACTERISTICS:
No NYHA class III-IV heart failure
No history of cerebrovascular accident, including transient ischemic attack, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months
PRIOR CONCURRENT THERAPY:
United States, District of Columbia | |
Howard University Cancer Center | Recruiting |
Washington, District of Columbia, United States, 20060 | |
Contact: Clinical Trials Office - Howard University Cancer Center 202-806-9122 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
United States, Minnesota | |
CCOP - Metro-Minnesota | Recruiting |
St. Louis Park, Minnesota, United States, 55416 | |
Contact: Thomas T. Amatruda, MD 952-993-1517 | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110-4803 | |
Contact: Gerald P. Linette, MD, PhD 314-747-7222 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
Australia, New South Wales | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Contact: Anne Hamilton, MD, FRACP 61-2-9515-5894 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital - Nedlands | Recruiting |
Perth, Western Australia, Australia, 6009 | |
Contact: Michael Millward, MD 61-8-9346-3823 millward@cyllene.uwa.edu.au |
Principal Investigator: | Amy Weise, DO | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000637188, MAYO-MC0875 |
Study First Received: | March 13, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00861913 History of Changes |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |