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Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer (SILVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003279
Recruitment Status : Completed
First Posted : August 25, 2004
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: BCG vaccine Biological: monoclonal antibody BEC2 Phase 3

Detailed Description:

OBJECTIVES: I. Determine the impact of adjuvant monoclonal antibody BEC2 and BCG on survival of patients with limited stage small cell lung cancer. II. Determine the safety of this regimen in these patients. III. Determine progression-free survival and quality of life of these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, Karnofsky performance status (60-70% vs 80-100%), and response to first-line combined modality treatment (complete vs partial). Within 3-7 weeks after completion of prior induction chemoradiotherapy, responding patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive best supportive care and are observed until disease progression is documented. Arm II: Patients receive adjuvant monoclonal antibody BEC2 and BCG intradermally on day 1 of weeks 0, 2, 4, 6, and 10. Treatment consists of 5 vaccinations over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, at weeks 6, 12, and 24, and then every 6 months thereafter. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 4 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
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 : March 1998
Primary Completion Date : January 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically proven limited stage small cell lung cancer (SCLC) Must have completed adequate first-line combined modality treatment comprising at least 4-6 courses of a 2-drug chemotherapy regimen and chest radiotherapy No evidence of disease progression or relapse Disease response (complete or partial) after treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater that 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal Hepatitis B negative Renal: Not specified Cardiovascular: Adequate cardiac function Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix No history of tuberculosis No grade 3 local skin toxicity reaction (ulceration) to 5 IU or greater of PPD test No active infections requiring systemic antibiotics, antiviral, or antifungal treatments No serious unstable chronic illnesses No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy with proteins of murine origin At least one month since prior immunotherapy No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent chronic use of systemic corticosteroids Radiotherapy: See Disease Characteristics No concurrent radiotherapy including prophylactic cranial irradiation No prior spleen radiotherapy Surgery: No prior surgery for SCLC No prior splenectomy Other: No prior second-line therapy for SCLC At least one month since prior investigational agents No concurrent chronic use of systemic antihistamines or nonsteroidal anti-inflammatory drugs No concurrent immunosuppressive therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003279

  Show 77 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center
More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003279     History of Changes
Other Study ID Numbers: EORTC-08971
First Posted: August 25, 2004    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic