Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

• ClinicalTrials.gov Identifier: NCT00037713
• Recruitment Status: Completed
• First Posted: May 21, 2002
• Last Update Posted: April 8, 2010
• Sponsor: Eli Lilly and Company
• Collaborators: Merck KGaA, Darmstadt, Germany; EORTC Lung Cancer Cooperative Group; Spanish Lung Cancer Group; Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK); US Department of Veterans Affairs; Groupe Francais De Pneumo-Cancerologie; Memorial Sloan Kettering Cancer Center; Independent centers (Australia, New Zealand, Europe, USA)
• Information provided by: Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Small Cell Lung	Biological: BEC2 Vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 515 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
• Study Start Date: September 1998
• Actual Primary Completion Date: October 2002
• Actual Study Completion Date: October 2002

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 1; Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
Experimental: 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	Biological: BEC2 Vaccine; 5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.

Outcome Measures

Primary Outcome Measures :

1. Overall survival [ Time Frame: 6 monthly basis until progression of disease ]

Secondary Outcome Measures :

1. Progression-free survival [ Time Frame: 6 monthly basis until progression of disease ]
2. Safety [ Time Frame: 6 monthly basis until progression of disease ]
3. Quality of Life [ Time Frame: 6 monthly basis until progression of disease ]
4. Health Economics Aspects [ Time Frame: 6 monthly basis until progression of disease ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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• Responsible Party: Chief Medical Officer, ImClone LLC
• ClinicalTrials.gov Identifier: NCT00037713
• Other Study ID Numbers: SILVA EORTC 08971
• First Posted: May 21, 2002
• Last Update Posted: April 8, 2010
• Last Verified: April 2010

Keywords provided by Eli Lilly and Company:

LD Small Cell Lung Cancer; BEC2, vaccine; adjuvant, monoclonal antibody; LD Small Cell Lung Cancer (VA Classification, Zelen, 1973)

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type