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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00276614 |
RATIONALE: Bortezomib 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 how well bortezomib works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bortezomib (Velcade ) Administered as a Single Agent in Metastatic Non-Clear Cell Renal Cell Carcinoma (RCC) Patients |
Estimated Enrollment: | 27 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then periodically for 2 years.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 |
Study Chair: | Matthew B. Rettig, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center at UCLA ( Matthew B. Rettig ) |
Study ID Numbers: | CDR0000453541, UCLA-0412011-01, MILLENNIUM-X05145 |
Study First Received: | January 12, 2006 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00276614 History of Changes |
Health Authority: | Unspecified |
stage IV renal cell cancer recurrent renal cell cancer papillary renal cell carcinoma |
Urinary Tract Neoplasm Chromophil Renal Cell Carcinoma Kidney Cancer Bortezomib Urogenital Neoplasms Urologic Neoplasms Recurrence Protease Inhibitors Carcinoma |
Renal Cancer Papillary Renal Cell Carcinoma Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Bortezomib Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Protease Inhibitors Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |