Recurrent Salivary Gland Carcinoma Clinical Trial
Official title:
A Phase 2 Study of Suberoylanilide Hydroxamic Acid (SAHA) in Subjects With Locally Advanced, Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
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.
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.
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