Lung CancerPhase 3SILVANCT00003279
Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
A Phase 3 study testing BCG vaccine and monoclonal antibody BEC2 in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 77 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- BCG vaccine and monoclonal antibody BEC2
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 77 sitesin 10 countries
- Study dates
- Mar 1998to Jan 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
77 sites in 10 countries.
77 sites in 10 countries
United States34 sites
Akron City Hospital
Akron, Ohio, 44309
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Charleston Area Medical Center
Charleston, West Virginia, 25304
Christ Hospital
Cincinnati, Ohio, 45219
Georgia Cancer Specialists
Decatur, Georgia, 30033
Colorado Permanente Medical Group, P.C.
Denver, Colorado, 80205
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
Benefis Healthcare
Great Falls, Montana, 59403
Great Falls Clinic
Great Falls, Montana, 59405
Greenwich Hospital Association
Greenwich, Connecticut, 06830
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Memorial Regional Cancer Center
Hollywood, Florida, 33021
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, 92037
Southwest Cancer Clinic
Las Vegas, Nevada, 89119
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Mercy Hospital
Miami, Florida, 33133
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Columbia - HCA Cancer Research Network
North Miami Beach, Florida, 33180
Norwich Cancer Center
Norwich, Connecticut, 06360
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Nevada - Reno
Reno, Nevada, 89520
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Bennett Cancer Center
Stamford, Connecticut, 06902
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Veterans Affairs Medical Center - West Roxbury
West Roxbury, Massachusetts, 02132
Spain13 sites
Hospital de Cruces
Barakaldo, Bilbao, E-48903
Hospital de la Santa Cruz I Sant Pau
Barcelona, 08025
Ciudad Sanitaria Vall D'Hebron
Barcelona, 08035
Hospital Clinic y Provincial de Barcelona
Barcelona, 08036
Hospital Nostra Senora Aranzazu
Donostia / San Sebastian
Hospital Universitario de Elche
Elche, E-03203
Hospital de la Princesa
Madrid, 28006
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario LA FE
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital General Universitario Valencia
Valencia, 46014
Hospital Arnau Vilanova
Valencia, 46015
Hospital Miguel Servet
Zaragoza, 50009
Australia11 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital, Sydney
Camperdown, New South Wales, 2050
Repatriation General Hospital
Concord, New South Wales, 2139
Monash Medical Center
East Bentweigh, Victoria, 3165
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, NSW 2310
Royal Melbourne Hospital
Parkville, Victoria, 3050
Nepean Hospital
Penrith, New South Wales, 2750
Royal Perth Hospital
Perth, Western Australia, 6000
Royal North Shore Hospital
St Leonards, New South Wales, 2065
NSW Breast Cancer Institute
Westmead, New South Wales, 2145
Germany5 sites
Universitaetsklinikum Benjamin Franklin
Berlin, D-12200
Asklepios Fachkliniken Munchen- Gauting
Gauting, Munich (Munchen), DOH-8-2131
Hospital Grosshansdorf
Großhansdorf, D-22927
Thoraxklinik Rohrbach
Heidelberg, D-69126
Marienhospital/Ruhr University Bochum
Herne, DOH-4-4625
Netherlands5 sites
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, 5211 NL
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, 1007 MB
Ziekenhuis St Jansdal
Harderwijk, 3840 AC
Sint Antonius Ziekenhuis
Nieuwegein, 3435 CM
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, 5042 AD
Switzerland4 sites
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Ratisches Kantons und Regionalspital
Chur, CH-7000
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
New Zealand2 sites
Green Lane Hospital
Auckland, 3
Wellington Cancer Centre
Wellington, 6039
About this study
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
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.
Read the 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
- Lung Cancer
- Being tested
- BCG vaccine, monoclonal antibody BEC2
- Keywords
- limited stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG vaccineBiological
monoclonal antibody BEC2Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2004 (estimated)
- Study startMar 1998
- Primary completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Giaccone, MD, PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003279
- Sponsor's protocol ID
- EORTC-08971
- Other IDs
- EORTC-08971, UCLA-9902001
- Acronym
- SILVA
- Status last verified
- Mar 2012
- First submitted
- 1 Nov 1999
- Last updated
- 6 Mar 2012
- Results posted
- No
Publications
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.
PubMed 18676140
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003279
- Acronym / sponsor ID
- SILVA / EORTC-08971
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Mar 1998
- Primary completion
- Jan 2000 (actual)
- First posted
- 25 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vaccine | Biological | – |
| monoclonal antibody BEC2 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Results publication: PubMed 18676140Bottomley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Giaccone, MD, PhD study chair
Universitair Ziekenhuis Brussel
77 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG vaccine and monoclonal antibody BEC2 in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 77 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Spain, Australia, Germany, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.