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RTOG 9909 Protocol Information

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A Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients with Completely Resected Stage I and Stage IIIA Non-Small Cell Lung Cancer
Protocol Documents
Current Version Date: 2/16/2005
Principal Investigator: Benjamin Movsas, M.D.
Primary Objective:
  • To prospectively measure the immune (i.e., humoral and T-cell) response to each of two anti-idiotype vaccines (in combination with radiation).
  • To determine the qualitative and quantitative toxicity (and reversibility of toxicity) of this regimen.
  • To determine the recurrence-free and overall survival in patients with completely resected stage II and IIIA NSCLC treated with immunotherapy plus thoracic radiotherapy.
Patient Population:
  • Histologically determined non-small cell lung cancer
  • Patients with pathologic N1 (hilar) and/or N2 nodal involvement from NSCLC which has been surgically resected (peribronchial N1only disease is excluded).
  • Zubrod Performance Status 0-1
  • Post-op FEV1 ≥ 1.0 L
  • ANC ≥ 2000/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 1.5 mg/dl
  • No incompletely resected gross disease; no microscopic positive bronchial or vascular margins
  • No brocho-alveolar carcinoma with lobar or multi-lobar involvement
  • No prior chemotherapy, thoracic radiation, or prior immunotherapy
  • No prior or concurrent malignancies, other than carcinoma in situ of the cervix and squamous/basal cell carcinoma of the skin, unless disease free for 3 years
  • Patients with superior vena cava syndrome are excluded.
  • No history of immune and immunodeficiency disorders; no active infection
  • No history of hypersensitivity or contraindications to study treatments
  • No history of colitis, inflammatory bowel disease, or pancreatitis within 10 years prior to first dose of study drugs
  • Pregnant or nursing women are excluded due to possible harmful effects of immunotherapy to the unborn child
  • Patients must sign a study-specific consent form
Target Accrual: 54
Current Accrual: 22
Status: Terminated
Date: 6/9/2009
Participating Sites:
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
Baptist Cancer Institute Jacksonville FL
Bay Area Tumor Institute Oakland CA
California Pacific Medical Center-Pacific Campus San Francisco CA
Caritas Regional Cancer Center Louisville KY
Case Western Reserve University Cleveland OH
Cleveland Clinic Akron General Akron OH
Community Medical Center Toms River NJ
Cottonwood Hospital Medical Center Murray UT
Covenant Medical Center-Lakeside Lubbock TX
Dixie Medical Center Regional Cancer Center East St. George UT
East Bay Radiation Oncology Center Castro Valley CA
Enloe Medical Center Chico CA
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Harbin Clinic Rome GA
Huntsman Cancer Institute/University of Utah Salt Lake City UT
Inspira Medical Center Vineland Vineland NJ
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Lexington Clinic Cancer Center Lexington KY
Liberty Hospital Liberty MO
McKay-Dee Hospital Center Ogden UT
McLaren Cancer Institute-Flint Flint MI
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Mills-Peninsula Medical Center San Mateo CA
Mobile Infirmary Medical Center Mobile AL
Monmouth Medical Center Long Branch NJ
Nebraska Methodist Hospital Omaha NE
Novant Health Forsyth Medical Center Winston Salem NC
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
Peninsula Regional Medical Center Salisbury MD
Providence St. Joseph Medical Center - Disney Family CA Ctr Burbank CA
Rapid City Regional Hospital Rapid City SD
Regional Hospital of Scranton Scranton PA
Saint Joseph Mercy Hospital Ann Arbor MI
Saint Luke's University Hospital-Bethlehem Campus Bethlehem PA
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Santa Rosa Memorial Hospital Santa Rosa CA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Sutter Cancer Research Consortium Novato CA
The Christ Hospital Cincinnati OH
Thomas Jefferson University Hospital Philadelphia PA
Tulane University Health Sciences Center New Orleans LA
UCSF Medical Center-Mount Zion San Francisco CA
United Hospital St. Paul MN
University of Cincinnati/Barrett Cancer Center Cincinnati OH
University of Florida Health Science Center - Gainesville Gainesville FL
University of Florida Health Science Center - Jacksonville Jacksonville FL
University of Missouri - Ellis Fischel Columbia MO
University of Rochester Rochester NY
University of Texas Medical Branch Galveston TX
UP Health System Marquette Marquette MI
Utah Valley Regional Medical Center Provo UT
Valley Medical Oncology Consultants Pleasanton CA
Vanderbilt University/Ingram Cancer Center Nashville TN
Virginia Mason CCOP Seattle WA
West Penn Hospital Pittsburgh PA
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/13/2011

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