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