Phase 1b Study of Human Fibroblast-based Vaccine for Resectable NSCLC
Researchers are evaluating the safety and efficacy of a vaccine for patients with resectable NSCLC.
Title: Active Immunization of Patients With Non Small Cell Lung Cancer (NSCLC) Using Fibroblasts Transfected With DNA From Autologous Tumor (Phase IB Study)1
Principal Investigators: Mark A Socinski, MD, UPCI/UPMC
Description: For this phase non-randomized 1b study, researchers are evaluating the safety and efficacy of a vaccine for patients with resectable NSCLC. The vaccine will consist of semi-allogeneic human fibroblasts transfected with NSCLC tumor DNA and will be irradiated prior to use.
All patients will undergo surgical resection prior to immunization. Part of the resected tumor will be used for DNA transfection.
The primary outcome is safety and feasibility; the secondary outcome is immune response.
The estimated enrollment for the study's first part is 15 patients. If at least 3 objective responses are noted, a further 22 patients will be enrolled.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT00793208.
Status: This study is open and recruiting patients as of November 29, 2017.
This study is sponsored by Theresa Whiteside, PhD, in collaboration with Immune Cell Therapy Inc.
- Clinicaltrials.gov. Immunization of patients with non small cell lung cancer (NSCLC). NCT00793208. https://clinicaltrials.gov/ct2/show/NCT00793208. Accessed November 29, 2017.