A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
Ancillary Trial: An exploratory investigation of immune response in peripheral blood after
L-BLP25 (or placebo) vaccination.
The ancillary study is a sub-study within START. This is a exploratory investigation of the
immune response in peripheral blood after L-BLP25 (or placebo) vaccination. The main
objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide
followed by L-BLP25 vaccinations induces specific immune response in peripheral blood to
BLP25 as well as a modulation of cellular and soluble components of the immune response in
patients with unresectable stage III NSCLC.
Twenty-five of the European START sites will participate in the ancillary study.
Sample size: up to 60 to 80 patients
All inclusion criteria specified in the START clinical trial protocol except for hemoglobin
≥ 100g/L
All exclusion criteria are the same as specified in the START clinical trial protocol
Schedule of events: Blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80mL
whole blood each)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To compare survival duration of all randomized subjects by treatment arm
Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths)
No
Frances Shepherd, MD, FRCPC
Principal Investigator
Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada
United States: Food and Drug Administration
EMR 63325-001
NCT00409188
December 2006
September 2014
Name | Location |
---|---|
University of Colorado Cancer Center | Denver, Colorado 80262 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
St. Vincents Comprehensive Cancer Center | New York, New York 10011 |
Deaconess Billings Clinic | Billings, Montana 59107-5100 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Glendale Adventist Medical Center | Glendale, California 91206 |
Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
Saint Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Clinical Trials and Research Associates, Inc. | Montebello, California 60460 |
Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
Desert Hematology Oncology Medical Group, Inc | Rancho Mirage, California 92270 |
Florida Hospital Memorial System | Ormond Beach, Florida 32174 |
Pacific Cancer Medical Center | Anaheim, California 92801 |
Pasco Hernando Oncology Associates, PA | New Port Richey, Florida 34642 |
Oncology Care Associates | St Joseph, Michigan 49085 |
University of Miami, Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Cancer Therapy & Research Center, Institute for Drug Development | San Antonio, Texas 78229 |
The Jones Clinic, Pc | Germantown, Tennessee 38138 |
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute | Los Angeles, California 90048 |
Norris Cancer Hospital | Los Angeles, California 90033 |
Stockton Hematology Oncology Medical Group, Inc. | Stockton, California 95204 |
Pasco Hernando Oncology Associates P.A | Brooksville, Florida 34613 |
Southern Illinois Hematology/Oncology | Centralia, Illinois 62801 |
Kentucky Cancer Center | Hazard, Kentucky 41701 |
Leonard J. Chabert Medical Center | Houma, Louisiana |
University of Maryland, Marlene and Steward Greenbaum Cancer Center | Baltimore, Maryland |
University of Minnesota Physicians, Masonic Cancer Center | Minneapolis, Minnesota |
Saint Louis University Cance Center | Saint Louis, Missouri |
Big Sky Oncology, Sletten Cancer Institute | Great Falls, Montana 59405 |
Nebraska Cancer Care, LLC | Hastings, Nebraska 68901 |
Hematology Oncology Associates of Rockland | Nyack, New York 10960 |
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |
Carolinas Hematology-Oncology | Charlotte, North Carolina 28203 |
Hanover Medical Specialts PA | Wilmington, North Carolina 28401 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Southwestern Regional Medical Center | Tulsa, Oklahoma 74133 |
Univ. of Pennsylvania Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
Center for Oncology Research | Dallas, Texas 75230 |
John Peter Smith Center for Cancer Care | Fort Worth, Texas 76104 |
Fairfax-Northern Virginia Hematology Oncology, PC | Fairfax, Virginia 22031 |