Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037713

Enrollment

515

Registered

2002-05-21

Start date

1998-09-30

Completion date

2002-10-31

Last updated

2010-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Small Cell Lung

Keywords

LD Small Cell Lung Cancer, BEC2, vaccine, adjuvant, monoclonal antibody, LD Small Cell Lung Cancer (VA Classification, Zelen, 1973)

Brief 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.

Interventions

BIOLOGICALBEC2 Vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histo-cytologically proven SCLC * Limited disease at diagnosis * Age greater than or equal to 18 * Patients with a clinical response of CR or PR to first line combined modality therapy * KPS greater than or equal to 60 * Adequate bone marrow, liver and heart functions * Written informed Consent

Exclusion criteria

* Prior surgical treatment for SCLC * History of tuberculosis * NCIC CTG grade 3 local skin toxicity reaction (ulceration) to \> IU PPD test \> 5 IU * HIV positive * Splenectomy or spleen radiation therapy in medical history * Prior therapy to proteins of murine origin * Any second line therapy for SCLC * Investigational agent or immune therapy within 4 weeks prior to study randomization * Severe active infections * Active infections requiring systemic antibiotics, antiviral, or antifungal treatments * Serious unstable chronic illness * The use of systemic anti-histamines, NSAID or systemic corticosteroids * Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence * Pregnancy or breast feeding or absence of adequate contraception for fertile patients * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.

Design outcomes

Primary

Measure	Time frame
Overall survival	6 monthly basis until progression of disease

Secondary

Measure	Time frame
Progression-free survival	6 monthly basis until progression of disease
Safety	6 monthly basis until progression of disease
Quality of Life	6 monthly basis until progression of disease
Health Economics Aspects	6 monthly basis until progression of disease

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026