Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Trial ID or NCT#
Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.
A Phase 2a Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
- - Metastatic small-cell lung cancer - Metastatic high-grade neuroendocrine carcinoma of any organ system (high-grade defined by Ki-67 ≥ 20% and/or ≥ 20 mitoses/10 (HPF). - Received at least one line of prior chemotherapy treatment for metastatic disease. - Daily chemotherapy must be completed ≥ 2 weeks prior to registration - Weekly chemotherapy must be completed ≥ 2 weeks prior to registration - Chemotherapy every 2 weeks must be completed ≥ 3 weeks prior to registration - Chemotherapy every 3 weeks must be completed ≥ 4 weeks prior to registration - ECOG Performance Status 0 to 2 - Measurable disease by RECIST 1.1 criteria - Age at least 18 years - Estimated life expectancy at least 3 months - Absolute neutrophil count ≥ 1,500/ mm³ - Platelets ≥ 100,000/mm³ - Hemoglobin ≥ 9 g/dL - Total bilirubin ≤ 1.5 mg/dL, OR ≤ 2 X ULN if tumor involves the liver - AST(SGOT) - ALT(SGPT) ≤ 3 X ULN - Creatinine ≤ 1.5 X ULN - Creatinine clearance ≥ 45 mL/min/1.73m²) for patients with creatinine levels above institutional normal - QT interval corrected using Fridericia's method (QTcF) < 450 msec (males) or < 470 msec (females) - PR < 240 msec - QRS < 100 msec - Brain metastases must be asymptomatic and have been adequately treated with radiation finishing at least 1 week prior to initiation of study treatment. - Ability to understand and the willingness to sign a written informed consent document.
- - Clinically-significant ventricular arrhythmia including cardiac arrest - Myocardial infarction from coronary artery disease within 3 months of study enrollment - Implantable pacemaker or implantable cardioverter defibrillator - NYHA Class III or greater congestive heart failure - Other clinically-significant cardiac disorders - Family history of long QT syndrome. - Concomitant or expected treatment with strong inhibitors of cytochrome p450 CYP2D6, specifically including Bupropion; Fluoxetine; or Paroxetine (must be discontinued at least 2 weeks or 5-half lives prior to the initiation of desipramine, whichever is shortest, except fluoxetine which requires at least a 5-week washout period). - Use of medications known to increase risk of torsades de pointes, including Amiodarone; Arsenic trioxide; Astemizole; Azithromycin; Bepridil; Chloroquine; Chlorpromazine; Cisapride; Citalopram; Clarithromycin; Disopyramide; Dofetilide; Domperidone; Droperidol; Erythromycin; Flecainide; Halofantrine; Haloperidol; Ibutilide; Levomethadyl; Mesoridazine; Methadone; Moxifloxacin; Pentamidine; Pimozide; Probucol; Procainamide; Quinidine; Sotalol; Sparfloxacin; Terfenadine; Thioridazine; Vandetanib - Other anti-depressant or anti-psychotic medications including selective serotonin re-uptake inhibitors (SSRIs); other tricyclic, monoamine oxidase inhibitors (MAOIs); serotonin-norepinephrine reuptake inhibitors (SNRIs, typical or atypical anti-psychotic) - Metoclopramide (Reglan) because of increased risk of extrapyrimidal symptoms and neuroleptic malignant syndrome - Symptomatic orthostatic hypotension despite adequate volume resuscitation. - Medical history of narrow angle glaucoma - Bipolar disorder, ongoing or active within the last 5 years - Suicidal ideation, ongoing or active within the last 5 years - Suicide attempt, ongoing or active within the last 5 years - Pregnancy - Breastfeeding - Receiving any other investigational agents - Any other serious or unstable concomitant systemic disorder that in the opinion of the investigator is incompatible with the clinical study
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