Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00788112
First received: November 7, 2008
Last updated: October 9, 2012
Last verified: October 2012
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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: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Vorinostat
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Reduction in Ki-67 compared to baseline Ki-67 [ Time Frame: 3 days prior to surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples [ Time Frame: 3 days prior to surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 17 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vorinostat | Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
Detailed Description:
OBJECTIVES:
- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women with ductal carcinoma in situ of the breast.
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 |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed (by core biopsy) ductal carcinoma in situ
- Stage 0 disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Potassium and magnesium levels normal
- Prothrombin time or INR ≤ 1.5 times upper limit of normal (ULN) (unless the patient is receiving therapeutic anticoagulation)
- Partial thromboplastin time ≤ 1.2 times ULN (unless the patient is receiving therapeutic anticoagulation)
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective barrier methods of contraception
- No known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements
- No active hepatitis A, B, or C infection
- No active HIV infection
- No other active infection
- No other malignancy within the past 5 years
- No condition that would interfere with the absorption or intake of vorinostat
- No history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior IV antibiotics, antivirals, or antifungals
- No prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat
- No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid
- No prior treatment with any other investigational agent
- No concurrent systemic steroids
- No concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other investigational therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788112
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Laura Esserman, MD, MBA | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00788112 History of Changes |
| Other Study ID Numbers: | CDR0000617655, UCSF-077532, H10367-31833, UCSF-07031833 |
| Study First Received: | November 7, 2008 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Data and Safety Monitoring Board |
Keywords provided by University of California, San Francisco:
|
ductal breast carcinoma in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013