Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

Trial ID or NCT#

NCT01719861

Status

not recruiting iconNOT RECRUITING

Purpose

Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.

Official Title

A Phase 2a Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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.
Exclusion Criteria:
  1. - 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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Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Associate Professor of Medicine (Oncology)
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Julien Sage
Alan F. Schatzberg
Alan F. Schatzberg
Psychiatrist
Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov