The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 主要终点
- Overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
1
Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
2
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:
- intolerable toxicity precluding further treatment progression of disease
- patient refusal
- occurrence of pregnancy
干预措施: BEC2 Vaccine (Biological)
结局指标
主要结局
Overall survival
时间窗: 6 monthly basis until progression of disease
次要结局
- 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)