The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG

OBJECTIVES:

• Determine the impact of vaccination with adjuvant BCG and monoclonal antibody BEC2 on the survival of patients with limited stage small cell lung cancer.
• Determine the progression free survival in these patients after receiving this treatment regimen.
• Determine the safety of this treatment regimen in these patients.
• Assess the quality of life in these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (60-70% vs 80-100%), and response to first line combined modality treatment (complete remission vs partial remission). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive vaccination with BCG and monoclonal antibody BEC2 intradermally on day 1 of weeks 0, 2, 4, 6, and 10 in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive no further therapy. Quality of life is assessed at baseline; at weeks 6, 12, and 24; and every 6 months thereafter until disease progression.

Patients are followed at 6 months, and then every 3 months thereafter.