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

March 5, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital, Sydney
      • Concord, New South Wales, Australia, 2139
        • Repatriation General Hospital
      • Newcastle, New South Wales, Australia, NSW 2310
        • Newcastle Mater Misericordiae Hospital
      • Penrith, New South Wales, Australia, 2750
        • Nepean Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2145
        • NSW Breast Cancer Institute
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Bentweigh, Victoria, Australia, 3165
        • Monash Medical Center
      • East Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Institute
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Vienna (Wein), Austria, A-1145
        • Pulmologisches Zentrum Der Stadt Wien
  • Belgium
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Germany
      • Berlin, Germany, D-12200
        • Universitaetsklinikum Benjamin Franklin
      • Gauting, Munich (Munchen), Germany, DOH-8-2131
        • Asklepios Fachkliniken Munchen- Gauting
      • Grosshansdorf, Germany, D-22927
        • Hospital Grosshansdorf
      • Heidelberg, Germany, D-69126
        • Thoraxklinik Rohrbach
      • Herne, Germany, DOH-4-4625
        • Marienhospital/Ruhr University Bochum
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Groot Ziekengasthuis 's-Hertogenbosch
      • Amsterdam, Netherlands, 1007 MB
        • Academisch Ziekenhuis der Vrije Universiteit
      • Harderwijk, Netherlands, 3840 AC
        • Ziekenhuis St Jansdal
      • Nieuwegein, Netherlands, 3435 CM
        • Sint Antonius Ziekenhuis
      • Tilburg, Netherlands, 5042 AD
        • Twee Steden Ziekenhuis Vestiging Tilburg
  • New Zealand
      • Auckland, New Zealand, 3
        • Green Lane Hospital
      • Wellington, New Zealand, 6039
        • Wellington Cancer Centre
  • Spain
      • Barakaldo, Bilbao, Spain, E-48903
        • Hospital de Cruces
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
      • Barcelona, Spain, 08035
        • Ciudad Sanitaria Vall D'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic y Provincial de Barcelona
      • Elche, Spain, E-03203
        • Hospital universitario de Elche
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • San Sebastian, Spain
        • Hospital Nostra Senora Aranzazu
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitario Valencia
      • Valencia, Spain, 46015
        • Hospital Arnau Vilanova
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Chur, Switzerland, CH-7000
        • Ratisches Kantons und Regionalspital
      • Saint Gallen, Switzerland, CH-9007
        • Kantonsspital - Saint Gallen
  • United Kingdom
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic and Research Foundation - La Jolla
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
    • Colorado
      • Denver, Colorado, United States, 80205
        • Colorado Permanente Medical Group, P.C.
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Hospital Association
      • Hartford, Connecticut, United States, 06105
        • St. Francis Hospital and Medical Center
      • Norwich, Connecticut, United States, 06360
        • Norwich Cancer Center
      • Stamford, Connecticut, United States, 06902
        • Bennett Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Cancer Center
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
      • Miami, Florida, United States, 33133
        • Mercy Hospital
      • North Miami Beach, Florida, United States, 33180
        • Columbia - HCA Cancer Research Network
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02132
        • Veterans Affairs Medical Center - West Roxbury
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Montana
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59403
        • Benefis Healthcare
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Southwest Cancer Clinic
      • Reno, Nevada, United States, 89520
        • University of Nevada - Reno
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
    • New York
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44309
        • Akron City Hospital
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Oncology Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Lubbock, Texas, United States, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

January 1, 2000

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 24, 2004

First Posted (Estimate)

August 25, 2004

Study Record Updates

Last Update Posted (Estimate)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08971
  • UCLA-9902001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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