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

NCT ID: NCT00037713

Last Updated: 2010-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30
• Study Completion Date: 2002-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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:

1. intolerable toxicity precluding further treatment progression of disease

2. patient refusal

3. occurrence of pregnancy

Group Type: EXPERIMENTAL

BEC2 Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

BEC2 Vaccine

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

EORTC Lung Cancer Cooperative Group

OTHER

Sponsor Role: collaborator

Spanish Lung Cancer Group

OTHER

Sponsor Role: collaborator

Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK)

UNKNOWN

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Independent centers (Australia, New Zealand, Europe, USA)

UNKNOWN

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

ImClone LLC

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Other Identifiers

SILVA EORTC 08971

Identifier Type: -

Identifier Source: org_study_id