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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499135 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best way to give sunitinib in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors.
Condition | Intervention | Phase |
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Kidney Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 3'-deoxy-3'-[18F]fluorothymidine Drug: sunitinib malate Procedure: computed tomography Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: positron emission tomography |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study. Patients are stratified according to diagnosis (renal cell carcinoma vs other solid malignancy). Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate.
Blood is collected for pharmacokinetic studies periodically during course 1 and on day 1 of each subsequent course. Samples are analyzed for VEGF and HIF1-α by enzyme-linked immunosorbent assay. Patients also undergo functional imaging by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans to measure tumor proliferation in correlation with plasma VEGF levels and HIF1-α levels.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
None of the following conditions are allowed:
No preexisting thyroid abnormality with an inability to maintain normal thyroid function with medication
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin
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 |
Principal Investigator: | George Wilding, MD | University of Wisconsin, Madison |
Study Chair: | Glenn Liu, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000552705, WCCC-CO-06902 |
Study First Received: | July 10, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00499135 |
Health Authority: | Unspecified |
clear cell renal cell carcinoma unspecified adult solid tumor, protocol specific recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases Sunitinib |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |