Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT00006352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453
Last updated 2012-07-18
Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. BCG may activate the immune system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer.
Conditions
Interventions
- BIOLOGICAL
-
BCG vaccine
- BIOLOGICAL
-
monoclonal antibody BEC2
Sponsors & Collaborators
-
European Organisation for Research and Treatment of Cancer - EORTC
lead NETWORK
Principal Investigators
-
Giuseppe Giaccone, MD, PhD · Free University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-09-30
- Primary Completion
- 2002-10-31
Countries
- Netherlands
Study Locations
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