CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
BEC2 Vaccinebiological
Likely dose
BEC2 Vaccine 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00037713
NCT00037713Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted May 21, 2002·Updated Apr 8, 2010

In Brief

A Phase 3 clinical trial evaluating BEC2 Vaccine for Carcinoma, Small Cell Lung. Completed, enrolled 515 participants.

Detailed Summary

This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Small Cell Lung
Countries--
CollaboratorsMerck KGaA, Darmstadt, Germany, EORTC Lung Cancer Cooperative Group, Spanish Lung Cancer Group, Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK), US Department of Veterans Affairs, Groupe Francais De Pneumo-Cancerologie, Memorial Sloan Kettering Cancer Center, Independent centers (Australia, New Zealand, Europe, USA)

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2002
Enrollment StartSep 1, 1998
Primary CompletionOct 1, 2002
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 24.1 years ago

Interventions

BEC2 Vaccinebiological

5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10.