The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Giuseppe Giaccone, MD, PhD
Study Chair
Free University Medical Center
United States: Federal Government
EORTC-08971
NCT00003279
March 1998
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Bridgeport Hospital | Bridgeport, Connecticut 06610 |
Christ Hospital | Cincinnati, Ohio 45219 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Bennett Cancer Center | Stamford, Connecticut 06902 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Great Falls Clinic | Great Falls, Montana 59405 |
Norwich Cancer Center | Norwich, Connecticut 06360 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
Southwest Cancer Clinic | Henderson, Nevada 89014 |
Scripps Clinic and Research Foundation - La Jolla | La Jolla, California 92037 |
Colorado Permanente Medical Group, P.C. | Denver, Colorado 80205 |
Greenwich Hospital Association | Greenwich, Connecticut 06830 |
St. Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Memorial Regional Cancer Center | Hollywood, Florida 33021 |
Mercy Hospital | Miami, Florida 33133 |
Columbia - HCA Cancer Research Network | North Miami Beach, Florida 33180 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Veterans Affairs Medical Center - West Roxbury | West Roxbury, Massachusetts 02132 |
Benefis Healthcare | Great Falls, Montana 59403 |
University of Nevada - Reno | Reno, Nevada 89520 |
Oklahoma Oncology Inc. | Tulsa, Oklahoma 74104 |
Charleston Area Medical Center | Charleston, West Virginia 25304 |