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

NCT00037713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2010-04-08

No results posted yet for this study

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.

Conditions

  • Carcinoma, Small Cell Lung

Interventions

BIOLOGICAL

BEC2 Vaccine

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EORTC Lung Cancer Cooperative Group

    collaborator OTHER

  • Spanish Lung Cancer Group

    collaborator OTHER

  • Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK)

    collaborator UNKNOWN

  • US Department of Veterans Affairs

    collaborator FED

  • Groupe Francais De Pneumo-Cancerologie

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER

  • Independent centers (Australia, New Zealand, Europe, USA)

    collaborator UNKNOWN

  • Eli Lilly and Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-30
Primary Completion
2002-10-31
Completion
2002-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00037713 on ClinicalTrials.gov