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

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01175980
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Oral Cavity Adenoid Cystic Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Salivary Gland Adenoid Cystic Carcinoma
  • Stage III Major Salivary Gland Cancer AJCC v7
  • Stage III Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Stage IVA Major Salivary Gland Cancer AJCC v7
  • Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Stage IVB Major Salivary Gland Cancer AJCC v7
  • Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Stage IVC Major Salivary Gland Cancer AJCC v7
  • Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Tongue Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 6, 2010
Status verified
Jul 2020
Primary completion
Jun 8, 2018
Completion
Aug 1, 2018

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vorinostat)
    Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response According to RECIST 1.1 Criteria [ Time Frame: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
Yale UniversityNew HavenConnecticut06520-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Case Comprehensive Cancer CenterClevelandOhio44106-5065-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Veterans AdministrationClevelandOhio44106-
Lake University Ireland Cancer CenterMentorOhio44060-
Ireland Cancer Center at Firelands Regional Medical CenterSanduskyOhio44870-

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