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Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer
This study has been completed.
First Received: August 16, 2005   Last Updated: January 15, 2009   History of Changes
Sponsor: California Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00132002
  Purpose

RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid 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 suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: vorinostat
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) as Salvage Therapy in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival at 6 months following study completion [ Designated as safety issue: No ]
  • Response rate at 6 months following study completion [ Designated as safety issue: No ]
  • Biologic end points at 6 months following study completion [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: June 2005
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective tumor response rate in patients with progressive stage IV adenocarcinoma of the breast treated with suberoylanilide hydroxamic acid as salvage therapy.

Secondary

  • Determine the time to progression and overall survival of patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Stage IV disease
  • Tumor blocks and/or slides from original diagnosis or metastatic disease work-up must be available
  • Progressive disease after 1 or 2 prior chemotherapy regimens for metastatic disease

    • Chemotherapy regimen(s) may have included trastuzumab (Herceptin®) for HER2/neu-positive disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
  • No known brain metastases unless they are controlled after prior therapy AND patient has not been treated with steroids within the past 2 months
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female or male

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 2 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal

Renal

  • Creatinine ≤ 1.6 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug, including any of the following:

    • Sodium butyrate
    • Trichostatin A
    • Trapoxin
    • MS-27-275
    • Depsipeptide
  • No psychiatric illness or social situation that would preclude study compliance
  • No ongoing or active infection
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • See Disease Characteristics
  • Prior hormonal therapy allowed

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • Prior adjuvant therapy for metastatic disease allowed
  • At least 2 weeks since prior valproic acid
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132002

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Thehang H. Luu, MD Beckman Research Institute
  More Information

Additional Information:
Publications:
Luu TH, Morgan RJ, Leong L, Lim D, McNamara M, Portnow J, Frankel P, Smith DD, Doroshow JH, Gandara DR, Aparicio A, Somlo G, Wong C. A phase II trial of vorinostat (suberoylanilide hydroxamic acid) in metastatic breast cancer: a California Cancer Consortium study. Clin Cancer Res. 2008 Nov 1;14(21):7138-42.
Luu TH, Leong L, Morgan R, et al.: Vorinostat (suberoylanilide hydroxamic acid) as salvage therapy in metastatic breast cancer (MBC): a California Cancer Consortium phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-11502, 2007.

Study ID Numbers: CDR0000438776, CCC-PHII-62, NCI-6918, NCI-P6918
Study First Received: August 16, 2005
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00132002     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
male breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Vorinostat
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010