Clinical trial NCT00086827 (phase 2, status: completed)
Conditions: recurrent small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: romidepsin
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
Eligibility criteria:

        Inclusion Criteria:

          -  Either histologic or cytologic documentation of recurrent small cell lung carcinoma
             (SCLC)

          -  No more than 1 prior chemotherapy regimen; must have recurrent disease after treatment
             with a platinum agent (either cisplatin or carboplatin); prior chemotherapy must have
             been completed ≥90 days prior to documentation of relapse

          -  >= 4 weeks since prior radiation therapy; prior radiation therapy is allowed either in
             the context of curative intent combined modality treatment for limited stage disease,
             prophylactic cranial radiation or palliative radiation (to the chest, brain, or other
             sites) initially or at relapse

          -  Prior surgery is allowed provided patients have completely recovered from effects of
             procedure and >= 2 weeks have elapsed

          -  No prior treatment with depsipeptide

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to depsipeptide

          -  No current treatment with any other investigational agent or drugs known to have HDI
             activity (HDAC or histone deacetylase inhibitor) such as sodium valproate

          -  Patients with treated/controlled brain mets (defined as no need for further radiation
             and no requirements for steroids to control peri-tumoral edema) are eligible for this
             study; however, patients requiring treatment with enzyme inducing anti-convulsant
             drugs are not eligible; these include, but are not limited to, phenytoin,
             phenobarbital, carbamazepine, felbamate and primidone

          -  All Patients must have Measurable Disease

               -  Measurable disease is defined as at least one lesion that can be accurately
                  measured in at least one dimension; the longest diameter of measurable lesions
                  must be >= 20 mm with conventional techniques or >= 10 mm with spiral CT scan;
                  lesions that are not considered measurable include the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

                    -  Tumor lesions situated in a previously irradiated area

          -  ECOG Performance Status 0-1

          -  No significant cardiac disease, including:

          -  Congestive heart failure that meets New York Heart Association (NYHA) class III/IV
             definitions, 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% by MUGA

          -  Evidence of left ventricular hypertrophy by echocardiographic criteria or by EKG
             criteria (Cornell voltage criteria):

        For Men: S in V3 plus R in aVL > 2.8 mV (28mm) For Women: S in V3 + R in aVL > 2.0 mV
        (20mm)

          -  Patients may not be co-medicated with an agent that causes QTc prolongation

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are not eligible because of possible
             pharmacokinetic interactions with depsipeptide

          -  No current treatment with potassium wasting diuretics (e.g., hydroclorothiazide);
             patients on such diuretics should be switched to a potassium sparing diuretic or
             another antihypertensive medication prior to registration

          -  Granulocytes >= 1,500/μl

          -  Platelets >= 100,000/μl

          -  Total Bilirubin =< 1.5 x ULN

          -  AST (SGOT) =< 2.5 x ULN

          -  Creatinine ≤1.5 x ULN OR Calculated Creatinine Clearance >= 60 ml/min

        Exclusion Criteria:

          -  Non-pregnant and non-nursing because of significant risk to the fetus/infant; the
             effects of depsipeptide on the developing human fetus at the recommended therapeutic
             dose are unknown; for this reason and because histone deacetylase inhibitors are known
             to be teratogenic, women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to and
             for the entire duration of participation and for at least 6 weeks after completion of
             treatment