Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer

This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).

Inclusion Criteria: * Small cell lung cancer (SCLC). * Patients must all have at least one measurable disease site using RECIST version 1.1 criteria. * Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the number of prior systemic treatment regimens. * Relapsed/refractory disease of any stage if incurable in nature, is eligible for enrollment. * Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative radiation treatment and 2-week washout is required for whole brain radiation treatment. Patients must have recovered from all clinically significant toxicity of last treatment and cleared the pharmacological agent(s) used previously. * ECOG performance status 0-1 (Karnofsky ≥60%). * Life expectancy greater than 6 months. * Patients must have normal organ and marrow function. * Triglyceride blood level (fasting) \460 milliseconds for women on baseline triplicate ECG, or psychiatric illness/social situations that would limit compliance with study requirements. * HIV-positive patients on combination antiretroviral therapy are ineligible. Patients with any active hepatitis infections. Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (e.g.: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma. * History of solid tumor malignancy other than the diseases under study, diagnosed within the last three (3) years of study enrollment, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment).