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

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003279
• Other study ID #: EORTC-08971
• Secondary ID: EORTC-08971UCLA-
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: March 5, 2012
• Start date: March 1998

Study information

• Verified date: March 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Biological:
• BCG vaccine

• monoclonal antibody BEC2

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital, Sydney	Camperdown	New South Wales
Australia	Repatriation General Hospital	Concord	New South Wales
Australia	Monash Medical Center	East Bentweigh	Victoria
Australia	Peter MacCallum Cancer Institute	East Melbourne	Victoria
Australia	Newcastle Mater Misericordiae Hospital	Newcastle	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Nepean Hospital	Penrith	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	NSW Breast Cancer Institute	Westmead	New South Wales
Austria	Pulmologisches Zentrum Der Stadt Wien	Vienna (Wein)
Belgium	U.Z. Gasthuisberg	Leuven
Germany	Universitaetsklinikum Benjamin Franklin	Berlin
Germany	Asklepios Fachkliniken Munchen- Gauting	Gauting, Munich (Munchen)
Germany	Hospital Grosshansdorf	Grosshansdorf
Germany	Thoraxklinik Rohrbach	Heidelberg
Germany	Marienhospital/Ruhr University Bochum	Herne
Netherlands	Groot Ziekengasthuis 's-Hertogenbosch	's-Hertogenbosch
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Ziekenhuis St Jansdal	Harderwijk
Netherlands	Sint Antonius Ziekenhuis	Nieuwegein
Netherlands	Twee Steden Ziekenhuis Vestiging Tilburg	Tilburg
New Zealand	Green Lane Hospital	Auckland
New Zealand	Wellington Cancer Centre	Wellington
Spain	Hospital de Cruces	Barakaldo, Bilbao
Spain	Ciudad Sanitaria Vall D'Hebron	Barcelona
Spain	Hospital Clinic y Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Cruz I Sant Pau	Barcelona
Spain	Hospital Universitario de Elche	Elche
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Nostra Senora Aranzazu	San Sebastian
Spain	Hospital Arnau Vilanova	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital General Universitario Valencia	Valencia
Spain	Hospital Universitario LA FE	Valencia
Spain	Hospital Miguel Servet	Zaragoza
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Ratisches Kantons und Regionalspital	Chur
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
United Kingdom	Royal Marsden Hospital	Sutton	England
United States	Akron City Hospital	Akron	Ohio
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Christ Hospital	Cincinnati	Ohio
United States	Georgia Cancer Specialists	Decatur	Georgia
United States	Colorado Permanente Medical Group, P.C.	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Benefis Healthcare	Great Falls	Montana
United States	Great Falls Clinic	Great Falls	Montana
United States	Greenwich Hospital Association	Greenwich	Connecticut
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	Memorial Regional Cancer Center	Hollywood	Florida
United States	Scripps Clinic and Research Foundation - La Jolla	La Jolla	California
United States	Southwest Cancer Clinic	Las Vegas	Nevada
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Mercy Hospital	Miami	Florida
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Columbia - HCA Cancer Research Network	North Miami Beach	Florida
United States	Norwich Cancer Center	Norwich	Connecticut
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Nevada - Reno	Reno	Nevada
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Bennett Cancer Center	Stamford	Connecticut
United States	Oklahoma Oncology Inc.	Tulsa	Oklahoma
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Veterans Affairs Medical Center - West Roxbury	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Germany,  Netherlands,  New Zealand,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 pati — View Citation