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

NCT00037713 | Completed Phase 3

• 1 other identifier: SILVA EORTC 08971
• Study Type: interventional
• Target: 515
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Small Cell Lung

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  6 monthly basis until progression of disease

Secondary Outcomes (4)

• 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

Study Arms (2)

1

NO INTERVENTION

Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.

2

EXPERIMENTAL

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

Biological: BEC2 Vaccine

Interventions

BEC2 Vaccine BIOLOGICAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Merck KGaA, Darmstadt, Germany: collaborator
• EORTC Lung Cancer Cooperative Group: collaborator
• Spanish Lung Cancer Group: collaborator
• Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK): collaborator
• US Department of Veterans Affairs: collaborator
• Groupe Francais De Pneumo-Cancerologie: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Independent centers (Australia, New Zealand, Europe, USA): collaborator

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MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2002
• First Posted: May 21, 2002
• Study Start: September 1, 1998
• Primary Completion: October 1, 2002
• Study Completion: October 1, 2002
• Last Updated: April 8, 2010

Record last verified: 2010-04