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

This study has been completed.
Sponsor:
Collaborators:
Merck KGaA
EORTC Lung Cancer Cooperative Group
Spanish Lung Cancer Group
Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK)
Centers of Veterans' Administration
Groupe Francais De Pneumo-Cancerologie
Memorial Sloan-Kettering Cancer Center
Independent centers (Australia, New Zealand, Europe, USA)
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00037713
First received: May 20, 2002
Last updated: April 7, 2010
Last verified: April 2010
  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:


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:

  1. intolerable toxicity precluding further treatment progression of disease
  2. patient refusal
  3. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:

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, Small Cell
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2014