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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00788112 |
Purpose
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat.
Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation.
After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed (by core biopsy) ductal carcinoma in situ
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| Principal Investigator: | E. Shelley Hwang, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Responsible Party: | UCSF Helen Diller Family Comprehensive Cancer Center ( E. Shelley Hwang ) |
| Study ID Numbers: | CDR0000617655, UCSF-077532, H10367-31833, UCSF-07031833 |
| Study First Received: | November 7, 2008 |
| Last Updated: | July 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00788112 History of Changes |
| Health Authority: | Unspecified |
|
ductal breast carcinoma in situ |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Carcinoma in Situ Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Breast Diseases Neoplasms by Histologic Type Skin Diseases Vorinostat |
Breast Neoplasms Enzyme Inhibitors Protective Agents Pharmacologic Actions Carcinoma Carcinoma, Ductal Neoplasms Analgesics, Non-Narcotic Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Neoplasms, Ductal, Lobular, and Medullary Peripheral Nervous System Agents Adenocarcinoma Antirheumatic Agents Central Nervous System Agents |