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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00330161 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with progressive metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: SAHA (Suberoylanilide Hydroxamic Acid) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of Suberoylanilide Hydroxamic Acid (NSC 701852) in Patients With Advanced Prostate Cancer That Has Progressed on One Prior Chemotherapy |
| Estimated Enrollment: | 29 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | June 2015 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Suberoylanilide Hydroxamic Acid (SAHA) Administration
Treatment will be administered on an outpatient basis continuously. Each cycle will be 21 days. Patients are to start treatment at -1 dose level of 300 mg/day for cycle 1. If tolerated, may increase to dose level 0 of 400 mg/day for subsequent cycles.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.
Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed prostate cancer
Prostate specific antigen (PSA) progression
Testosterone < 50 ng/dL
PATIENT CHARACTERISTICS:
Patients who require additional diagnostic testing due to either history or clinical findings must meet the following additional criteria:
No other "currently active" malignancy other than nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer investigational or commercial agents or therapies, including hormonal agents such as steroids, megestrol, or antiandrogens, or herbal medications
No concurrent oral anti-androgens
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
More Information
| Responsible Party: | Dr. Maha Hussain, The University of Michigan Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00330161 History of Changes |
| Other Study ID Numbers: | CDR0000478886, CCUM-HUM00002854, UMCC-2005.127, NCI-6862 |
| Study First Received: | May 25, 2006 |
| Last Updated: | September 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage IV prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |