Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG
- Conditions
- Carcinoma, Small Cell Lung
- Interventions
- Biological: BEC2 Vaccine
- Registration Number
- NCT00037713
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 BEC2 Vaccine 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
- Primary Outcome Measures
Name Time Method Overall survival 6 monthly basis until progression of disease
- Secondary Outcome Measures
Name Time Method 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