Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Vaccines

Immunoglobulins

BCG Vaccine

Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.

Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur:

1. intolerable toxicity precluding further treatment progression of disease
2. patient refusal
3. occurrence of pregnancy

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

BEC2 Vaccine

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.

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

Merck 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)

Eli Lilly and Company

Chief Medical Officer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG	NCT00037713	Carcinoma, Smal...	BEC2 Vaccine	18 Years -	Eli Lilly and Company
Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG	NCT00037713	Carcinoma, Smal...	BEC2 Vaccine	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for bec2 vaccine

Every month we try and update this database with for bec2 vaccine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.