Clinical Trials Directory

Trials / Completed

CompletedNCT01175980

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

A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
30 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well vorinostat works in treating patients with adenoid cystic carcinoma that has come back (recurrent) or that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy by means of response rate (based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) of vorinostat in the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC). SECONDARY OBJECTIVES: I. To characterize the safety and tolerability of vorinostat in this patient population. II. To assess the time to tumor response (TTR). III. To assess the response duration (RD). IV. To evaluate progression free survival (PFS). V. To assess overall survival (OS). TERTIARY OBJECTIVES: I. To assess the association between a metabolic response by positron emission tomography (PET)/computed tomography (CT) after one cycle of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST). II. To assess the association between a metabolic response by PET/CT after the first and second chemotherapy cycle and PFS. III. To assess flow sort diploid, aneuploid, and tetraploid populations of tumor cells from formalin fixed, paraffin-embedded (FFPE) tissue blocks from patients who benefited from suberoylanilide hydroxamic acid (SAHA) therapy and from patients who did not demonstrate a durable benefit. IV. Profile the genomes of each cell population using oligonucleotide comparative genomic hybridization (CGH) arrays. V. Perform whole exome analysis of the sorted tumor population and matching germ line sample for each of the patients selected. VI. To assess stable disease duration (SDD). VII. To assess the association between response to vorinostat treatment and RAD23 homolog B (HR23B) on tumor paraffin blocks. VIII. Retrospectively compare volumetric density (viable tumor volume = VTV) with pre-determined RECIST of target lesions in cross sectioning imaging (CT/magnetic resonance \[MR\]) already obtained. IX. Correlate VTV, RECIST and treatment response (partial response, stable disease, progressive disease and stable disease over 6 months). OUTLINE: Patients receive vorinostat orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for 180 days.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGVorinostatGiven PO

Timeline

Start date
2010-08-06
Primary completion
2018-06-08
Completion
2018-08-01
First posted
2010-08-05
Last updated
2020-08-03
Results posted
2020-08-03

Locations

12 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01175980. Inclusion in this directory is not an endorsement.