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

Carcinoma, Small Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037713
• Other study ID #: SILVA EORTC 08971
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2002
• Last updated: April 7, 2010
• Start date: September 1998
• Est. completion date: October 2002

Study information

• Verified date: April 2010
• Source: ImClone LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Carcinoma, Small Cell Lung
• Small Cell Lung Carcinoma

Intervention

Biological:
• BEC2 Vaccine
5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
ImClone LLC	Centers of Veterans' Administration, EORTC Lung Cancer Cooperative Group, Groupe Francais De Pneumo-Cancerologie, Independent centers (Australia, New Zealand, Europe, USA), Memorial Sloan Kettering Cancer Center, Merck KGaA, Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK), Spanish Lung Cancer Group

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		6 monthly basis until progression of disease	No
Secondary	Progression-free survival		6 monthly basis until progression of disease	No
Secondary	Safety		6 monthly basis until progression of disease	Yes
Secondary	Quality of Life		6 monthly basis until progression of disease	No
Secondary	Health Economics Aspects		6 monthly basis until progression of disease	No