Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: romidepsin
Intervention description: Given IV
Intervention MeSH terms: Romidepsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well FR901228 works in treating patients with
      unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck.
      Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from
      dividing so they stop growing or die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically confirmed squamous cell cancer of the head and neck
             (MedDRA code 90002024), excluding nasopharyngeal primaries, which is unresectable or
             metastatic; the disease must be incurable with surgery or radiation therapy; the tumor
             should preferably be present at the primary site, and it must be accessible to planned
             biopsy methods

          -  Measurable disease by RECIST,

          -  May have received any number of prior systemic chemotherapy regimen for unresectable,
             recurrent or metastatic disease; if the only site of measurable disease is a
             previously irradiated area, the patient must have documented progressive disease or
             biopsy-proven residual carcinoma; persistent disease after radiotherapy must be
             biopsy-proven at least 8 weeks after the completion of radiotherapy

          -  Life expectancy of greater than 3 months

          -  Normal organ and marrow function as defined by the following labs performed =< 2 weeks
             of study entry:

          -  Leukocytes ≥ 3,000/uL

          -  Absolute Neutrophil Count ≥ 1,500/uL

          -  Hemoglobin ≥ 10 gm%

          -  Platelets ≥ 100,000/uL

          -  Total Bilirubin =< 1.5 X upper normal institutional limit

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X upper normal institutional limits

          -  Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73
             m^2 for patients with creatinine levels above institutional normal

          -  PT/PTT =< 1.1X upper normal institutional limits

          -  Calcium within normal institutional limits

          -  CPK, Troponin within normal institutional limits

          -  Uric Acid within normal institutional limits

          -  Ability to understand and the willingness to sign a written informed consent document;
             in addition to consent for the therapy, patients must give consent to required pre-
             and post-therapy blood and tissue samples;

        Exclusion Criteria:

          -  Patients should not have had prior therapy with depsipeptide and may not be receiving
             any other investigational agents or drugs known to have histone deacetylase inhibitor
             activity such as sodium valproate

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  Significant cardiac disease including congestive heart failure that meets New York
             Heart Association (NYHA) class III and IV definitions (see Appendix II), history of
             myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or
             poorly controlled angina

          -  History of serious ventricular arrhythmia (VT or VF, > 3 beats in a row), QTc > 500
             msec, or LVEF < 40%

          -  Patients may not be co-medicated with an agent that causes QTc prolongation; -
             Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Not pregnant or lactating

          -  History of HIV infection