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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BCG vaccine
monoclonal antibody BEC2
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Mayo Clinic Scottsdale
  • Scripps Clinic and Research Foundation - La Jolla
  • Jonsson Comprehensive Cancer Center, UCLA
  • Colorado Permanente Medical Group, P.C.
  • Bridgeport Hospital
  • Greenwich Hospital Association
  • St. Francis Hospital and Medical Center
  • Norwich Cancer Center
  • Bennett Cancer Center
  • Veterans Affairs Medical Center - Washington, DC
  • Memorial Regional Cancer Center
  • Mercy Hospital
  • Sylvester Cancer Center, University of Miami
  • Columbia - HCA Cancer Research Network
  • Emory University School of Medicine
  • Georgia Cancer Specialists
  • Veterans Affairs Medical Center - West Roxbury
  • CCOP - Metro-Minnesota
  • Benefis Healthcare
  • Great Falls Clinic
  • Southwest Cancer Clinic
  • University of Nevada - Reno
  • Veterans Affairs Medical Center - East Orange
  • Veterans Affairs Medical Center - Buffalo
  • Memorial Sloan-Kettering Cancer Center
  • Duke Comprehensive Cancer Center
  • Akron City Hospital
  • Christ Hospital
  • Oklahoma Oncology Inc.
  • Rhode Island Hospital
  • Joe Arrington Cancer Research and Treatment Center
  • Charleston Area Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Royal Prince Alfred Hospital, Sydney
  • Repatriation General Hospital
  • Newcastle Mater Misericordiae Hospital
  • Nepean Hospital
  • Royal North Shore Hospital
  • NSW Breast Cancer Institute
  • Royal Adelaide Hospital
  • Monash Medical Center
  • Peter MacCallum Cancer Institute
  • Royal Melbourne Hospital
  • Royal Perth Hospital
  • Pulmologisches Zentrum Der Stadt Wien
  • U.Z. Gasthuisberg
  • Universitaetsklinikum Benjamin Franklin
  • Asklepios Fachkliniken Munchen- Gauting
  • Hospital Grosshansdorf
  • Thoraxklinik Rohrbach
  • Marienhospital/Ruhr University Bochum
  • Groot Ziekengasthuis 's-Hertogenbosch
  • Academisch Ziekenhuis der Vrije Universiteit
  • Ziekenhuis St Jansdal
  • Sint Antonius Ziekenhuis
  • Twee Steden Ziekenhuis Vestiging Tilburg
  • Green Lane Hospital
  • Wellington Cancer Centre
  • Hospital de Cruces
  • Hospital de la Santa Cruz I Sant Pau
  • Ciudad Sanitaria Vall D'Hebron
  • Hospital Clinic y Provincial de Barcelona
  • Hospital Universitario de Elche
  • Hospital de la Princesa
  • Hospital Universitario 12 de Octubre
  • Hospital Nostra Senora Aranzazu
  • Hospital Universitario LA FE
  • Hospital Clinico Universitario de Valencia
  • Hospital General Universitario Valencia
  • Hospital Arnau Vilanova
  • Hospital Miguel Servet
  • University Hospital
  • Inselspital, Bern
  • Ratisches Kantons und Regionalspital
  • Kantonsspital - Saint Gallen
  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 5, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003279
Brief Title
Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Acronym
SILVA
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
BCG vaccine
Intervention Type
Biological
Intervention Name(s)
monoclonal antibody BEC2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giaccone, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Scripps Clinic and Research Foundation - La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Colorado Permanente Medical Group, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Greenwich Hospital Association
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Norwich Cancer Center
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Bennett Cancer Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Memorial Regional Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Columbia - HCA Cancer Research Network
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Cancer Specialists
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Veterans Affairs Medical Center - West Roxbury
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59403
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Southwest Cancer Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
University of Nevada - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89520
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oklahoma Oncology Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal Prince Alfred Hospital, Sydney
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
NSW 2310
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
NSW Breast Cancer Institute
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Center
City
East Bentweigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Pulmologisches Zentrum Der Stadt Wien
City
Vienna (Wein)
ZIP/Postal Code
A-1145
Country
Austria
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Asklepios Fachkliniken Munchen- Gauting
City
Gauting, Munich (Munchen)
ZIP/Postal Code
DOH-8-2131
Country
Germany
Facility Name
Hospital Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
D-22927
Country
Germany
Facility Name
Thoraxklinik Rohrbach
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Marienhospital/Ruhr University Bochum
City
Herne
ZIP/Postal Code
DOH-4-4625
Country
Germany
Facility Name
Groot Ziekengasthuis 's-Hertogenbosch
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Academisch Ziekenhuis der Vrije Universiteit
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Ziekenhuis St Jansdal
City
Harderwijk
ZIP/Postal Code
3840 AC
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis Vestiging Tilburg
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Green Lane Hospital
City
Auckland
ZIP/Postal Code
3
Country
New Zealand
Facility Name
Wellington Cancer Centre
City
Wellington
ZIP/Postal Code
6039
Country
New Zealand
Facility Name
Hospital de Cruces
City
Barakaldo, Bilbao
ZIP/Postal Code
E-48903
Country
Spain
Facility Name
Hospital de la Santa Cruz I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Ciudad Sanitaria Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Elche
City
Elche
ZIP/Postal Code
E-03203
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Nostra Senora Aranzazu
City
San Sebastian
Country
Spain
Facility Name
Hospital Universitario LA FE
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General Universitario Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Arnau Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Ratisches Kantons und Regionalspital
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18676140
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.
Results Reference
result

Learn more about this trial

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

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