The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
- 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
- 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
- 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.
PROJECTED ACCRUAL: A total of 570 patients (285 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Giuseppe Giaccone, MD, PhD
Free University Medical Center
United States: Federal Government