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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00037713

Collaborator

Merck KGaA, Darmstadt, Germany (Industry), EORTC Lung Cancer Cooperative Group (Other), Spanish Lung Cancer Group (Other), Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK) (Other), US Department of Veterans Affairs (U.S. Fed), Groupe Francais De Pneumo-Cancerologie (Other), Memorial Sloan Kettering Cancer Center (Other), Independent centers (Australia, New Zealand, Europe, USA) (Other)

515

Enrollment

Arms

Duration (Months)

Study Details

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

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 :

Sep 1, 1998

Actual Primary Completion Date :

Oct 1, 2002

Actual Study Completion Date :

Oct 1, 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.

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

Overall survival [6 monthly basis until progression of disease]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.