Pilot study of 1650-G: a simplified cellular vaccine for lung cancer.

Introduction: Cancer immunotherapy is a conceptually attractive since it is highly specific and can deal with disseminated disease with minimal impact on normal tissues. Early phase clinical trials have well established the ability of a variety of immunotherapeutic approaches to induce antigen specific immune responses in lung cancer patients. Although no immunotherapy is likely to be a panacea, recent data from randomized phase IIB studies offer promise of therapeutic activity in both early and late stage lung cancer.

Methods: This report describes early clinical experience with vaccine 1650-G, an allogeneic cellular vaccine using granulocyte macrophage colony stimulating factor as an adjuvant. This nonrandomized pilot study was conducted at four sites in the Commonwealth of Kentucky with primary objective of determining biological activity in a relevant patient population; the use of similar antigen source, immunization schedule, and immunological assessment facilitated comparison to DC vaccines previously tested by our group.

Results: Data indicates 1650-G is safe and generated a robust and unequivocal immunological response in 6/11 of immunized patients. The relative frequency and kinetics of the response appears similar to that achieved with DC vaccines (1650+autologous DC). The fact that this vaccine could be transported and delivered to cancer patients in community cancer clinics also fulfills an important objective of our research.

Conclusions: These findings provide critical foundation for further testing of this simple, and comparatively inexpensive multivalent NSCLC vaccine.