Immunization of Small Cell Lung Cancer Patients With a Pentavalent Vaccine Composed of KLH-conjugates of GD2L, GD3L, Globo H, Fucosyl GM1, and N-Propionylated Polysialic Acid
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirm the safety of the pentavalent vaccine in this patient population
After immunization with a pentavalent vaccine, including KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid, with the adjuvant OPT-821. Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The vaccination will be considered safe if no more than 1 patient has new grade 2 neurotoxicity, grade 3 hepatotoxicity, new autoimmunity or grade 4 local or grade 3 systemic toxicity requiring cessation of treatment.
Lee Krug, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|