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Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Trial ID: NCT01719861
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
- ALT(SGPT) ≤ 3 X ULN
- Creatinine ≤ 1.5 X ULN
- Creatinine clearance ≥ 45 mL/min/1.73m²) for patients with creatinine levels above
- QT interval corrected using Fridericia's method (QTcF) < 450 msec (males) or < 470
- 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;
- 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
- 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
- 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
drug: Desipramine HCL
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