Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma

Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
This study is currently recruiting participants.
Verified September 2011 by Barbara Ann Karmanos Cancer Institute

First Received on August 4, 2010.  
Last Updated on October 18, 2011  
History of Changes
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01175980
  Purpose

RATIONALE: Vorinostat may 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 locally advanced, recurrent, or metastatic adenoid cystic carcinoma.

Condition Intervention Phase
Head and Neck Cancer Drug: vorinostat
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC) (IND 71976)

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:

  • Objective response as measured by RECIST criteria [ Time Frame: Every 8 weeeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Time to response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: Assessed every 8 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Assessed evry 8 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Assessed weekly ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: Assessed at 180 days after last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: September 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:

    Drug: vorinostat

    continuous daily oral regimen at 400mg PO

    Other: laboratory biomarker analysis

    Detection of ACC-associated Onco- and Tumor Suppressor Proteins in Tumor Tissue

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the efficacy, in terms of response rate, of vorinostat in patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC).

Secondary

  • To characterize the safety and tolerability of this regimen in this patients.
  • To assess the time to tumor response in patients treated with this regimen.
  • To assess the response duration in patients treated with this regimen.
  • To evaluate progression-free survival (PFS) of patients treated with this regimen.
  • To assess the overall survival of patients treated with this regimen.

Tertiary

  • To assess the association between a metabolic response by PET/CT scan after one course of chemotherapy and subsequent best tumor response.
  • To assess the association between a metabolic response by PET/CT scan after the first and second chemotherapy courses and PFS.
  • To assess the association between response and biomarkers such as c-kit, HER2/neu, EGFR, p21, p16, p53, TBP2 on tumor paraffin blocks.
  • To assess the association between response, acetylation of histones, and levels of HR23B in peripheral blood mononuclear cells.
  • To assess the association between response and genomic biomarkers in tumor tissue.
  • To characterize molecular mechanisms of vorinostat response in ACC and identify novel therapeutic strategies.
  • To develop a series of primary tumorgrafts from trial participants in support of future ACC research and experimental therapeutics.

OUTLINE: Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples may be collected at baseline and on days 7 and 28 for analysis of acetylation of surrogate proteins and HDAC biomarkers in peripheral blood mononuclear cells. Achieved tumor tissue samples from biopsy may also be analyzed for genomic biomarkers.

After completion of study therapy, patients are followed up for 6 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 adenoid cystic carcinoma

    • Locally advanced, recurrent, and/or metastatic disease not amenable to potentially curative surgery or radiotherapy
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm by spiral CT scan
  • Available primary tumor tissue (either fresh or from paraffin block)
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • Life expectancy > 12 weeks
  • ECOG performance status 0-2 ( Karnofsky 60-100%)
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • No other prior malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix, unless curatively treated and no evidence of disease within the past 5 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to and for the duration of study participation
  • Able to take oral medications on a continuous basis
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition of vorinostat
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • Any prior number of chemotherapy regimens allowed
  • At least 4 weeks since prior chemotherapy or radiotherapy (6 weeks for carmustine, nitrosoureas, or mitomycin C) and recovered
  • At least 4 weeks since prior valproic acid
  • More than 21 days since prior major surgery
  • No prior vorinostat
  • No concurrent enzyme-inducing anticonvulsants
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175980

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Patricia LoRusso     313-576-8716        
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:

No publications provided

Responsible Party: Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01175980    
History of Changes
Other Study ID Numbers: CDR0000682704, P30CA022453, WSU-2009-165
Study First Received: August 4, 2010
Last Updated: October 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:

recurrent adenoid cystic carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent salivary gland cancer
salivary gland adenoid cystic carcinoma
stage III salivary gland cancer
stage IV salivary gland cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms by Site
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2012

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