Clinical trial · Interventional
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
NCT00037713CI-TRIAL-00003339completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell Lung | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEC2 Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- 1
- description
- Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
- type
- EXPERIMENTAL
- label
- 2
- description
- 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
- interventionNames
- Biological: BEC2 Vaccine
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 6 monthly basis until progression of disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (27)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDSprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life. Qual Life Res. 1993 Aug;2(4):287-95. doi: 10.1007/BF00434800. PMID 8220363
- BACKGROUNDStiggelbout AM, Eijkemans MJ, Kiebert GM, Kievit J, Leer JW, De Haes HJ. The 'utility' of the visual analog scale in medical decision making and technology assessment. Is it an alternative to the time trade-off? Int J Technol Assess Health Care. 1996 Spring;12(2):291-8. doi: 10.1017/s0266462300009648. PMID 8707502
- BACKGROUNDChapman PB, Houghton AN. Induction of IgG antibodies against GD3 ganglioside in rabbits by an anti-idiotypic monoclonal antibody. J Clin Invest. 1991 Jul;88(1):186-92. doi: 10.1172/JCI115276. PMID 2056117
- BACKGROUNDDunn PL, Johnson CA, Styles JM, Pease SS, Dean CJ. Vaccination with syngeneic monoclonal anti-idiotype protects against a tumour challenge. Immunology. 1987 Feb;60(2):181-6. PMID 3817870
- BACKGROUNDErtl HC, Finberg RW. Sendai virus-specific T-cell clones: induction of cytolytic T cells by an anti-idiotypic antibody directed against a helper T-cell clone. Proc Natl Acad Sci U S A. 1984 May;81(9):2850-4. doi: 10.1073/pnas.81.9.2850. PMID 6326148
- BACKGROUNDFuentes R, Allman R, Mason MD. Ganglioside expression in lung cancer cell lines. Lung Cancer. 1997 Aug;18(1):21-33. doi: 10.1016/s0169-5002(97)00049-4.