Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
Condition: 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
MeSH terms: Carcinoma; Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic; Recurrence
Intervention: Laboratory Biomarker Analysis; Vorinostat
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed locally advanced,
             recurrent or metastatic adenoid cystic carcinoma

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm by chest x-ray, as >= 10 mm with CT scan, or >= 10 mm with calipers by clinical
             exam; all tumor measurements must be recorded in millimeters (or decimal fractions of
             centimeters)

          -  Patients must have locally advanced and/or recurrent and/or metastatic disease not
             amenable to potentially curative surgery or radiotherapy; any prior number of
             chemotherapy regimens is allowed; a minimum of at least 4 weeks since prior
             chemotherapy or radiation therapy should have elapsed, 6 weeks if the last regimen
             included carmustine (BCNU) or mitomycin C

          -  Life expectancy of greater than 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits (WNL)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 x institutional upper limit of normal (ULN)

          -  Creatinine within normal institutional limits or

          -  Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal

          -  Eligibility of patients receiving any medications or substances known to affect or
             with the potential to affect the activity or pharmacokinetics of vorinostat will be
             determined following review of their case by the principal investigator

          -  No other diagnosis of malignancy unless non-melanoma skin cancer, carcinoma in situ of
             the cervix, or a malignancy diagnosed >= 5 years previously and currently with no
             evidence of disease; however - if the patient has had a previously diagnosed stage
             I/II malignancy of another type, consideration for recruitment may be made by the
             Cancer Therapy Evaluation Program (CTEP) senior investigator after discussion with
             local principal investigator (PI) and patient's physician

          -  Confirmed availability of tumor tissue (either fresh or from paraffin block) from the
             primary tumor or metastatic site to be available to use on correlative studies

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document

          -  If the patient's tumor can be easily accessed, a pre-treatment biopsy will be
             mandatory

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier;
             more than 21 days from major surgery should have elapsed before the first dose of the
             study drug

          -  Patients may not be receiving any other investigational agents or have received
             vorinostat in the past; patients should not have taken valproic acid for at least 4
             weeks prior to enrollment

          -  Inability to take oral medications on a continuous basis

          -  Patients with active brain metastases should be excluded from this clinical trial;
             patients with previous brain metastases will be eligible if condition is treated and
             stable for >= 1 month

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SAHA

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with vorinostat

          -  Patient is unable or unwilling to abide by the study protocol and to cooperate fully
             with the investigator or designee

          -  Patient on current therapy with enzyme-inducing anticonvulsants