Lung Cancer Clinical Trial
Official title:
The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with
monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who
have limited-stage small cell lung cancer.
OBJECTIVES: I. Determine the impact of adjuvant monoclonal antibody BEC2 and BCG on survival
of patients with limited stage small cell lung cancer. II. Determine the safety of this
regimen in these patients. III. Determine progression-free survival and quality of life of
these patients treated with this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, Karnofsky performance status (60-70% vs 80-100%), and response to first-line
combined modality treatment (complete vs partial). Within 3-7 weeks after completion of
prior induction chemoradiotherapy, responding patients are randomized to 1 of 2 treatment
arms. Arm I: Patients receive best supportive care and are observed until disease
progression is documented. Arm II: Patients receive adjuvant monoclonal antibody BEC2 and
BCG intradermally on day 1 of weeks 0, 2, 4, 6, and 10. Treatment consists of 5 vaccinations
over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed at baseline, at weeks 6, 12, and 24, and then every
6 months thereafter. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 4 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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