A Phase IIa Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Intrapatient dose escalation of desipramine. Start at 75 mg daily. Increase by 75 mg weekly to maximum of 450 mg daily. Taper desipramine upon disease progression, unacceptable toxicity or patient withdrawal from study.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : desipramine
Phase: Phase 2
Ages Eligible For Study:
- Metastatic small-cell lung cancer -or- 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. After progression on first-line chemotherapy, disease does not have to have progressed on subsequent lines of therapy to enroll on trial. - Completed previous treatment in greater than or equal to the following times prior to initiation of study treatment: - Chemotherapy administered in a daily schedule must be completed >= 2 weeks prior to registration; - Chemotherapy administered in a weekly schedule must be completed >= 2 weeks prior to registration; - Chemotherapy administered in a 2-weekly schedule must be completed >= 3 weeks prior to registration; - Chemotherapy administered in a 3-weekly schedule must be completed >= 4 weeks prior to registration. - ECOG Performance Status 0-2 - Measurable disease by RECIST 1.1 criteria - Age at least 18 years-old otherwise no age, gender/race-ethnic restrictions - At least 3 months estimated life expectancy. - Laboratory tests within the following parameters: - Absolute neutrophil count >= 1,500/ mm3 - Platelets >= 100,000/mm3 - Hemoglobin >= 9 g/Dl - Total bilirubin <= 1.5 mg/dL - AST(SGOT) and ALT(SGPT) <= 3 X ULN (Stanford: AST(SGOT) ULN 60, ALT (SGPT) ULN 80). - Creatinine <=1.5 X ULN (Stanford: ULN 1.1) -or- Calculated (See Appendix F for Cockgroft-Gault formula) measured creatinine clearance >= 45 mL/min/1.73m2 (normalized to BSA) for patients with creatinine levels above institutional normal - ECG demonstrating all of the following: - QT interval corrected using Fridericia's method (QTcF) <450 msec (males) or <470 msec (females) (see Appendix E for Fredericia's criteria). - PR <240 msec - QRS <100 msec - Brain metastases are allowed, but 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.