## Protocol Section
### Identification Module
**NCT ID:** NCT00003279

**Acronym:** SILVA

**Brief Title:** Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

**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

#### Organization Study ID Info
**ID:** EORTC-08971
#### Organization
**Class:** NETWORK
**Full Name:** European Organisation for Research and Treatment of Cancer - EORTC
#### Secondary ID Infos
**ID:** EORTC-08971
**ID:** UCLA-9902001
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-03-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-03-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2000-01

**Type:** ACTUAL

#### Start Date
**Date:** 1998-03

**Status Verified Date:** 2012-03

#### Study First Post Date
**Date:** 2004-08-25
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-01
**Study First Submit QC Date:** 2004-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** European Organisation for Research and Treatment of Cancer - EORTC

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Lung Cancer

**Keywords:**

- limited stage small cell lung cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** BCG vaccine

**Type:** BIOLOGICAL

#### Intervention 2

**Name:** monoclonal antibody BEC2

**Type:** BIOLOGICAL

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** University of Alabama Comprehensive Cancer Center

**State:** Alabama

**Zip:** 35294

**Location 2:**

**City:** Scottsdale

**Country:** United States

**Facility:** Mayo Clinic Scottsdale

**State:** Arizona

**Zip:** 85259

**Location 3:**

**City:** La Jolla

**Country:** United States

**Facility:** Scripps Clinic and Research Foundation - La Jolla

**State:** California

**Zip:** 92037

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** Jonsson Comprehensive Cancer Center, UCLA

**State:** California

**Zip:** 90095-1781

**Location 5:**

**City:** Denver

**Country:** United States

**Facility:** Colorado Permanente Medical Group, P.C.

**State:** Colorado

**Zip:** 80205

**Location 6:**

**City:** Bridgeport

**Country:** United States

**Facility:** Bridgeport Hospital

**State:** Connecticut

**Zip:** 06610

**Location 7:**

**City:** Greenwich

**Country:** United States

**Facility:** Greenwich Hospital Association

**State:** Connecticut

**Zip:** 06830

**Location 8:**

**City:** Hartford

**Country:** United States

**Facility:** St. Francis Hospital and Medical Center

**State:** Connecticut

**Zip:** 06105

**Location 9:**

**City:** Norwich

**Country:** United States

**Facility:** Norwich Cancer Center

**State:** Connecticut

**Zip:** 06360

**Location 10:**

**City:** Stamford

**Country:** United States

**Facility:** Bennett Cancer Center

**State:** Connecticut

**Zip:** 06902

**Location 11:**

**City:** Washington

**Country:** United States

**Facility:** Veterans Affairs Medical Center - Washington, DC

**State:** District of Columbia

**Zip:** 20422

**Location 12:**

**City:** Hollywood

**Country:** United States

**Facility:** Memorial Regional Cancer Center

**State:** Florida

**Zip:** 33021

**Location 13:**

**City:** Miami

**Country:** United States

**Facility:** Mercy Hospital

**State:** Florida

**Zip:** 33133

**Location 14:**

**City:** Miami

**Country:** United States

**Facility:** Sylvester Cancer Center, University of Miami

**State:** Florida

**Zip:** 33136

**Location 15:**

**City:** North Miami Beach

**Country:** United States

**Facility:** Columbia - HCA Cancer Research Network

**State:** Florida

**Zip:** 33180

**Location 16:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University School of Medicine

**State:** Georgia

**Zip:** 30322

**Location 17:**

**City:** Decatur

**Country:** United States

**Facility:** Georgia Cancer Specialists

**State:** Georgia

**Zip:** 30033

**Location 18:**

**City:** West Roxbury

**Country:** United States

**Facility:** Veterans Affairs Medical Center - West Roxbury

**State:** Massachusetts

**Zip:** 02132

**Location 19:**

**City:** Saint Louis Park

**Country:** United States

**Facility:** CCOP - Metro-Minnesota

**State:** Minnesota

**Zip:** 55416

**Location 20:**

**City:** Great Falls

**Country:** United States

**Facility:** Benefis Healthcare

**State:** Montana

**Zip:** 59403

**Location 21:**

**City:** Great Falls

**Country:** United States

**Facility:** Great Falls Clinic

**State:** Montana

**Zip:** 59405

**Location 22:**

**City:** Las Vegas

**Country:** United States

**Facility:** Southwest Cancer Clinic

**State:** Nevada

**Zip:** 89119

**Location 23:**

**City:** Reno

**Country:** United States

**Facility:** University of Nevada - Reno

**State:** Nevada

**Zip:** 89520

**Location 24:**

**City:** East Orange

**Country:** United States

**Facility:** Veterans Affairs Medical Center - East Orange

**State:** New Jersey

**Zip:** 07018-1095

**Location 25:**

**City:** Buffalo

**Country:** United States

**Facility:** Veterans Affairs Medical Center - Buffalo

**State:** New York

**Zip:** 14215

**Location 26:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan-Kettering Cancer Center

**State:** New York

**Zip:** 10021

**Location 27:**

**City:** Durham

**Country:** United States

**Facility:** Duke Comprehensive Cancer Center

**State:** North Carolina

**Zip:** 27710

**Location 28:**

**City:** Akron

**Country:** United States

**Facility:** Akron City Hospital

**State:** Ohio

**Zip:** 44309

**Location 29:**

**City:** Cincinnati

**Country:** United States

**Facility:** Christ Hospital

**State:** Ohio

**Zip:** 45219

**Location 30:**

**City:** Tulsa

**Country:** United States

**Facility:** Oklahoma Oncology Inc.

**State:** Oklahoma

**Zip:** 74104

**Location 31:**

**City:** Providence

**Country:** United States

**Facility:** Rhode Island Hospital

**State:** Rhode Island

**Zip:** 02903

**Location 32:**

**City:** Lubbock

**Country:** United States

**Facility:** Joe Arrington Cancer Research and Treatment Center

**State:** Texas

**Zip:** 79410-1894

**Location 33:**

**City:** Charleston

**Country:** United States

**Facility:** Charleston Area Medical Center

**State:** West Virginia

**Zip:** 25304

**Location 34:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin Comprehensive Cancer Center

**State:** Wisconsin

**Zip:** 53792

**Location 35:**

**City:** Camperdown

**Country:** Australia

**Facility:** Royal Prince Alfred Hospital, Sydney

**State:** New South Wales

**Zip:** 2050

**Location 36:**

**City:** Concord

**Country:** Australia

**Facility:** Repatriation General Hospital

**State:** New South Wales

**Zip:** 2139

**Location 37:**

**City:** Newcastle

**Country:** Australia

**Facility:** Newcastle Mater Misericordiae Hospital

**State:** New South Wales

**Zip:** NSW 2310

**Location 38:**

**City:** Penrith

**Country:** Australia

**Facility:** Nepean Hospital

**State:** New South Wales

**Zip:** 2750

**Location 39:**

**City:** St. Leonards

**Country:** Australia

**Facility:** Royal North Shore Hospital

**State:** New South Wales

**Zip:** 2065

**Location 40:**

**City:** Westmead

**Country:** Australia

**Facility:** NSW Breast Cancer Institute

**State:** New South Wales

**Zip:** 2145

**Location 41:**

**City:** Adelaide

**Country:** Australia

**Facility:** Royal Adelaide Hospital

**State:** South Australia

**Zip:** 5000

**Location 42:**

**City:** East Bentweigh

**Country:** Australia

**Facility:** Monash Medical Center

**State:** Victoria

**Zip:** 3165

**Location 43:**

**City:** East Melbourne

**Country:** Australia

**Facility:** Peter MacCallum Cancer Institute

**State:** Victoria

**Zip:** 8006

**Location 44:**

**City:** Parkville

**Country:** Australia

**Facility:** Royal Melbourne Hospital

**State:** Victoria

**Zip:** 3050

**Location 45:**

**City:** Perth

**Country:** Australia

**Facility:** Royal Perth Hospital

**State:** Western Australia

**Zip:** 6000

**Location 46:**

**City:** Vienna (Wein)

**Country:** Austria

**Facility:** Pulmologisches Zentrum Der Stadt Wien

**Zip:** A-1145

**Location 47:**

**City:** Leuven

**Country:** Belgium

**Facility:** U.Z. Gasthuisberg

**Zip:** B-3000

**Location 48:**

**City:** Berlin

**Country:** Germany

**Facility:** Universitaetsklinikum Benjamin Franklin

**Zip:** D-12200

**Location 49:**

**City:** Gauting, Munich (Munchen)

**Country:** Germany

**Facility:** Asklepios Fachkliniken Munchen- Gauting

**Zip:** DOH-8-2131

**Location 50:**

**City:** Grosshansdorf

**Country:** Germany

**Facility:** Hospital Grosshansdorf

**Zip:** D-22927

**Location 51:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Thoraxklinik Rohrbach

**Zip:** D-69126

**Location 52:**

**City:** Herne

**Country:** Germany

**Facility:** Marienhospital/Ruhr University Bochum

**Zip:** DOH-4-4625

**Location 53:**

**City:** 's-Hertogenbosch

**Country:** Netherlands

**Facility:** Groot Ziekengasthuis 's-Hertogenbosch

**Zip:** 5211 NL

**Location 54:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Academisch Ziekenhuis der Vrije Universiteit

**Zip:** 1007 MB

**Location 55:**

**City:** Harderwijk

**Country:** Netherlands

**Facility:** Ziekenhuis St Jansdal

**Zip:** 3840 AC

**Location 56:**

**City:** Nieuwegein

**Country:** Netherlands

**Facility:** Sint Antonius Ziekenhuis

**Zip:** 3435 CM

**Location 57:**

**City:** Tilburg

**Country:** Netherlands

**Facility:** Twee Steden Ziekenhuis Vestiging Tilburg

**Zip:** 5042 AD

**Location 58:**

**City:** Auckland

**Country:** New Zealand

**Facility:** Green Lane Hospital

**Zip:** 3

**Location 59:**

**City:** Wellington

**Country:** New Zealand

**Facility:** Wellington Cancer Centre

**Zip:** 6039

**Location 60:**

**City:** Barakaldo, Bilbao

**Country:** Spain

**Facility:** Hospital de Cruces

**Zip:** E-48903

**Location 61:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de la Santa Cruz I Sant Pau

**Zip:** 08025

**Location 62:**

**City:** Barcelona

**Country:** Spain

**Facility:** Ciudad Sanitaria Vall D'Hebron

**Zip:** 08035

**Location 63:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clinic y Provincial de Barcelona

**Zip:** 08036

**Location 64:**

**City:** Elche

**Country:** Spain

**Facility:** Hospital Universitario de Elche

**Zip:** E-03203

**Location 65:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital de la Princesa

**Zip:** 28006

**Location 66:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario 12 de Octubre

**Zip:** 28041

**Location 67:**

**City:** San Sebastian

**Country:** Spain

**Facility:** Hospital Nostra Senora Aranzazu

**Location 68:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital Universitario LA FE

**Zip:** 46009

**Location 69:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital Clinico Universitario de Valencia

**Zip:** 46010

**Location 70:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital General Universitario Valencia

**Zip:** 46014

**Location 71:**

**City:** Valencia

**Country:** Spain

**Facility:** Hospital Arnau Vilanova

**Zip:** 46015

**Location 72:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Hospital Miguel Servet

**Zip:** 50009

**Location 73:**

**City:** Basel

**Country:** Switzerland

**Facility:** University Hospital

**Zip:** CH-4031

**Location 74:**

**City:** Bern

**Country:** Switzerland

**Facility:** Inselspital, Bern

**Zip:** CH-3010

**Location 75:**

**City:** Chur

**Country:** Switzerland

**Facility:** Ratisches Kantons und Regionalspital

**Zip:** CH-7000

**Location 76:**

**City:** Saint Gallen

**Country:** Switzerland

**Facility:** Kantonsspital - Saint Gallen

**Zip:** CH-9007

**Location 77:**

**City:** Sutton

**Country:** United Kingdom

**Facility:** Royal Marsden Hospital

**State:** England

**Zip:** SM2 5PT

#### Overall Officials

**Official 1:**

**Affiliation:** Free University Medical Center

**Name:** Giuseppe Giaccone, MD, PhD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Bottomley A, Debruyne C, Felip E, Millward M, Thiberville L, D'Addario G, Rome L, Zatloukal P, Coens C, Giaccone G. Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer. Eur J Cancer. 2008 Oct;44(15):2178-84. doi: 10.1016/j.ejca.2008.06.036.

**PMID:** 18676140

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M28323

- Name: Small Cell Lung Carcinoma

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T5271

- Name: Small Cell Lung Cancer

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000055752

- Term: Small Cell Lung Carcinoma

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000276

- Term: Adjuvants, Immunologic

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: Chemotherapy

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M4793

- Name: BCG Vaccine

- Relevance: HIGH

- As Found: Right and left

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

- ID: D000000911

- Term: Antibodies, Monoclonal

- ID: D000001500

- Term: BCG Vaccine

### Misc Info Module

- Version Holder: 2024-05-24
