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

Purpose

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	Intervention	Phase
Carcinoma, Small Cell Lung	Biological: BEC2 Vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by ImClone LLC:

Primary Outcome Measures:

Overall survival [ Time Frame: 6 monthly basis until progression of disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: 6 monthly basis until progression of disease ] [ Designated as safety issue: No ]
Safety [ Time Frame: 6 monthly basis until progression of disease ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: 6 monthly basis until progression of disease ] [ Designated as safety issue: No ]
Health Economics Aspects [ Time Frame: 6 monthly basis until progression of disease ] [ Designated as safety issue: No ]

Enrollment:	515
Study Start Date:	September 1998
Study Completion Date:	October 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 History of Changes
Other Study ID Numbers:	SILVA EORTC 08971
Study First Received:	May 20, 2002
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by ImClone LLC:

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

Additional relevant MeSH terms:

Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013