drugset / Trial / NCT01799161

Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer

NCT01799161

Phase 1 Withdrawn Eckhard Podack
RandomizedParallel-groupOpen-labelTreatment

Summary

NSCLC tumors are appropriate targets for active immunotherapy, because they are non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune response. NSCLC tumor-secreted gp96-Ig is an ideal vaccine because it combines adjuvant activity with polyvalent peptide specificity. Tumor secreted gp96 activates dendritic cells (DC), natural killer cells (NK) and cytotoxic T lymphocytes (CTL). Tumor cells can be killed by NK-specific mechanisms, by promiscuous killing of CD8 CTL through NKG2D, and by MHC restricted CD8 CTL activity. The activation of DC and NK by tumor secreted gp96 may also counteract the generation of immuno-suppressive CD4 regulatory cells. Suppression of adenosinergic pathways by oxygen and theophylline in combination with immunotherapy will improve tumor rejection. Allogeneic, gp96-Ig secreting tumor cells used as vaccine are expected to generate NK and CTL with activity to the patient's autologous tumor.

Timeline

Start
2014-12
Primary completion
2018-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator vitespen Vaccine 1e+07 cells Intravitreal
Comparator vitespen Vaccine 2e+07 cells Intravitreal
Comparator vitespen Vaccine 4e+07 cells Intravitreal
Comparator Theophylline Small molecule 300 mg