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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324870 |
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat when given together with bevacizumab and to see how well they work in treating patients with unresectable or metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: bevacizumab Drug: vorinostat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With the VEGF Inhibitor Bevacizumab in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 42 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
(Phase II)
Secondary
(Phase II)
OUTLINE: This is a phase I, dose-escalation study of vorinostat (SAHA) followed by a phase II study.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 42 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 renal cell carcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR
The following histologies are not allowed:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Michael A. Carducci ) |
Study ID Numbers: | CDR0000467800, JHOC-J0570, JHOC-00001107, NCI-6884 |
Study First Received: | May 10, 2006 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00324870 History of Changes |
Health Authority: | Unspecified |
clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Anticarcinogenic Agents Anti-Inflammatory Agents Urinary Tract Neoplasm Kidney Cancer Vorinostat Urogenital Neoplasms Bevacizumab Urologic Neoplasms Angiogenesis Inhibitors Recurrence Carcinoma Renal Cancer |
Urologic Diseases Analgesics, Non-Narcotic Kidney Neoplasms Carcinoma, Renal Cell Clear Cell Renal Cell Carcinoma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Kidney Diseases Antirheumatic Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Bevacizumab Urologic Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Growth Inhibitors |
Angiogenesis Modulating Agents Kidney Diseases Analgesics Neoplasms by Histologic Type Growth Substances Vorinostat Enzyme Inhibitors Angiogenesis Inhibitors Protective Agents Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents |