Clinical trial NCT00087295 (phase 2, status: terminated)
Conditions: bladder cancer, transitional cell cancer of the renal pelvis and ureter, urethral cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: depsipeptide
SMILES: C\C=C1/NC(=O)[C@H]2CSSCC\C=C\[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@@H](NC1=O)C(C)C
Reason stopped: 
    permanently closed due to poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal
             pelvis, ureter, or urethra)

               -  Metastatic disease

                    -  Node-positive, non-metastatic disease that is unresectable is allowed

               -  Poorly differentiated transitional cell carcinoma OR predominant transitional
                  cell carcinoma with rare foci of squamous differentiation or rare foci of
                  adenocarcinoma allowed

          -  The following histologic types are not allowed:

               -  Adenocarcinoma

               -  Small cell carcinoma

               -  Sarcoma

               -  Squamous cell carcinoma

               -  Mixed adeno/squamous/transitional histology

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques
                  OR ≥ 1 cm by spiral CT scan

               -  Soft tissue disease irradiated within the past 2 months is not considered
                  measurable

          -  Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy
             regimen that included cisplatin or carboplatin for metastatic disease

          -  Not curable by surgery or radiotherapy

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  White blood cell (WBC) count ≥ 3,000/mm^3

        Hepatic

          -  Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper
             limit of normal (ULN)

          -  Bilirubin normal

        Renal

          -  Creatinine ≤ 2 times ULN

        Cardiovascular

          -  Corrected QT interval (QTc) < 500 msec

          -  Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA)

          -  No New York Heart Association class III or IV congestive heart failure

          -  No myocardial infarction within the past year

          -  No uncontrolled dysrhythmias

          -  No poorly controlled angina

          -  No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation
             ≥ 3 beats in a row)

          -  No left ventricular hypertrophy on EKG

          -  No other significant cardiac disease

        Other

          -  Potassium ≥ 4 mmol/L

          -  Magnesium ≥ 2 mg/dL

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No prior allergic reaction to compounds of similar chemical or biological composition
             to FR901228 (depsipeptide)

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  At least 28 days since prior chemotherapy

          -  No prior FR901228 (depsipeptide)

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  More than 28 days since prior radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  More than 28 days since prior surgery

        Other

          -  Recovered from all prior therapy

          -  More than 28 days since prior intravesical therapy

          -  No concurrent hydrochlorothiazide

          -  No concurrent agent that causes QTc prolongation

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational histone deacetylase inhibitor agents or drugs
             (e.g., sodium valproate)

          -  No other concurrent anticancer therapy