Clinical trial NCT00390117 (phase 1, status: completed)
Conditions: lymphoma, unspecified adult solid tumor, protocol specific
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: cdki at7519
SMILES: ClC1=CC=CC(Cl)=C1C(=O)NC1=CNN=C1C(=O)NC1CCNCC1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed diagnosis of 1 of the following:

               -  Advanced and/or metastatic solid tumor

                    -  No more than 3 prior regimens for metastatic disease

               -  Refractory non-Hodgkin's lymphoma

          -  Clinically or radiologically documented disease

               -  Patients whose only evidence of disease is tumor marker elevation are not
                  eligible

          -  No untreated brain or meningeal metastases

               -  Patients with radiologic or clinical evidence of stable, treated brain metastases
                  are eligible provided they are asymptomatic AND have no requirement for
                  corticosteroids

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50
             mL/min

          -  Bilirubin normal

          -  ALT and AST ≤ 2 times ULN (5 times ULN if patient has documented liver metastases)

          -  Potassium normal

          -  Calcium normal

          -  Creatine kinase (CK or CPK) ≤ 2 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction,
             including any of the following:

               -  Significant cardiac event (including symptomatic heart failure or angina) within
                  the past 3 months or any cardiac disease that, in the opinion of the
                  investigator, increases the risk for ventricular arrhythmia

               -  Any history of ventricular arrhythmia, which was symptomatic or required
                  treatment (CTC grade 3), including multifocal PVCs, bigeminy, trigeminy, or
                  ventricular tachycardia

               -  Uncontrolled hypertension

               -  Previous history of QT prolongation with other medication

               -  Congenital long QT syndrome

               -  QT and QTc, with Bazett's correction, unmeasurable or ≥ 460 msec on screening ECG

               -  LVEF < 45 % by MUGA for patients with significant cardiac history (i.e.,
                  myocardial infarction, severe hypertension, or arrhythmia) or prior doxorubicin
                  (> 450 mg/m²)

          -  No active or uncontrolled infections

          -  No serious illness or medical condition that would preclude study compliance

          -  No peripheral neuropathy > grade 1

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 21 days since prior cytotoxic chemotherapy and recovered (solid tumors)

          -  At least 21 days since prior palliative radiotherapy and recovered

               -  Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy

          -  Prior hormonal, immunologic, biologic, or signal transduction inhibitor therapy
             allowed

          -  At least 14 days since prior major surgery and recovered (no nonhealing wounds)

          -  At least 4 weeks since prior steroids

          -  No other concurrent medications which affect QT/QTc and cannot be discontinued

          -  No other concurrent experimental drugs or anticancer therapy