Know Cancer

forgot password

Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer


- Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10
anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with
radiotherapy in patients with completely resected stage II or IIIA non-small cell lung

- Determine the qualitative and quantitative toxicity and reversibility of toxicity of
this regimen in these patients.

- Determine the progression-free and overall survival of patients treated with this

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1
anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning
2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2
years regardless of disease progression. Beginning no more than 1 week after the third
postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks.
Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional
radiotherapy boosts.

Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year,
every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed stage II or IIIA non-small cell lung cancer

- T1-3, N1-2, M0

- No stage IIIB (e.g., contralateral N3), stage IV (M1), or T3, N0, M0 disease

- N1 disease eligible only if hilar lymph node involvement present

- No bronchoalveolar carcinoma with lobar or multilobar involvement

- No small cell lung carcinoma, including mixed histology

- No more than 7 weeks since prior surgery (lobectomy, sleeve resection, bilobectomy,
or pneumonectomy)

- Negative surgical margins

- No incompletely resected gross disease OR

- No microscopically positive bronchial or vascular margins

- No known CNS metastasis



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Not specified


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- No superior vena cava syndrome


- FEV_1 at least 1.0 L


- No prior celiac disease, familial polyposis, Turcot's syndrome, Gardner's syndrome,
Peutz-Jegher's syndrome, or hereditary non-polyposis colon cancer

- No prior colitis, inflammatory bowel disease, or pancreatitis within the past 10


- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known sensitivity to rodent proteins

- No prior hypersensitivity or contraindication to study treatments (e.g., monoclonal
antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1 anti-idiotype vaccine,
aluminum hydroxide, or murine proteins) or any excipients

- No prior clinically significant hypersensitivity reactions (e.g., angioedema,
anaphylaxis, or serious dermatological manifestations) or asthmatic attacks requiring

- No prior immune or immunodeficiency disorders (e.g., HIV, sarcoidosis, tuberculosis,
rheumatoid arthritis, or autoimmune disorders)

- No prior seizure disorder requiring continuous medication

- No active infection

- No other prior or concurrent malignancy within the past 3 years except surgically
treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

- No medical contraindication to surgery, radiotherapy, or immunotherapy

- No prior drug or alcohol abuse (excluding nicotine) within the past 12 months

- No prior psychiatric or addictive disorder that would preclude study compliance


Biologic therapy:

- No prior murine antibodies (e.g., OncoScint scan)

- No prior monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1
anti-idiotype vaccine, or other investigational carcinoembryonic antigen-derived

- At least 3 years since other prior immunotherapy

- At least 30 days since prior immunization (e.g., influenza)

- No immunomodulatory therapy (e.g., gold, auranofin, hydroxychloroquine,
sulfasalazine, penicillamine, levamisole, dapsone, azathioprine, intravenous
immunoglobulin, leukotriene antagonists, cromoglycate, ketotifen, nedocromil,
psoralin-ultraviolet-light, or plasmapheresis) within 30 prior to the first dose of
study drug or 5 half-lives of the action of the agent, whichever is longer


- At least 3 years since prior chemotherapy except topical therapy

- No concurrent methotrexate or cyclophosphamide

Endocrine therapy:

- At least 45 days since prior corticosteroids

- No concurrent systemic corticosteroids


- No prior thoracic radiotherapy


- See Disease Characteristics


- At least 45 days since prior immunosuppressants

- No investigational agents within 30 prior to the first dose of study drug or 5
half-lives of the action of the agent, whichever is longer

- No concurrent amifostine

- No concurrent cyclosporine

- No other concurrent immunosuppressants

- No concurrent chronic systemic antihistamines

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Benjamin Movsas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Akron City Hospital Akron, Ohio  44304
Roswell Park Cancer Institute Buffalo, New York  14263
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Sylvester Cancer Center, University of Miami Miami, Florida  33136
Hurley Medical Center Flint, Michigan  48503
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Bloomington Hospital Bloomington, Indiana  47402
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Ochsner New Orleans, Louisiana  70121
Rapid City Regional Hospital Rapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Henry Ford Hospital Detroit, Michigan  48202
Marshfield Clinic Marshfield, Wisconsin  54449
Huntsville Hospital System Huntsville, Alabama  35801
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Loma Linda University Medical Center Loma Linda, California  92354
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Radiation Oncology Center - Sacramento Sacramento, California  95816
O'Connor Hospital San Jose, California  95128
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
University of Florida Health Science Center Gainesville, Florida  32610-0296
Baptist Hospital of Miami Miami, Florida  33176-2197
Florida Radiation Oncology Group Orange Park, Florida  32073
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology Center Sarasota, Florida  34233
Medical Center/John B. Amos Community Cancer Center Columbus, Georgia  31902
Northwest Community Hospital Arlington Heights, Illinois  60005
Northwestern Memorial Hospital Chicago, Illinois  60611
Ingalls Memorial Hospital Harvey, Illinois  60426
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Central Illinois Springfield, Illinois  62526
St. John's Medical Center Anderson, Indiana  46016
Ball Memorial Hospital Muncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louisville Radiation Oncology Louisville, Kentucky  40215
Merle M. Mahr Cancer Center Madisonville, Kentucky  42431
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Tulane University School of Medicine New Orleans, Louisiana  70112
Maine Medical Center Portland, Maine  04102
Anne Arundel Oncology Center Annapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer Center Baltimore, Maryland  21204
Harbor Hospital Center Baltimore, Maryland  21225
Cape Cod Hospital Hyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer Center Flint, Michigan  48432
Marquette General Hospital Marquette, Michigan  49855
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Elliot Regional Cancer Center Manchester, New Hampshire  03103
John F. Kennedy Medical Center Edison, New Jersey  08818
Newark Beth Israel Medical Center Newark, New Jersey  07112
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
New York Methodist Hospital Brooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Northeast Medical Center Concord, North Carolina  28025
Akron General Medical Center Akron, Ohio  44302
Christ Hospital Cincinnati, Ohio  45219
University Hospitals of Cleveland Cleveland, Ohio  44106
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Philadelphia Philadelphia, Pennsylvania  19104
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Mercy Hospital of Pittsburgh Pittsburgh, Pennsylvania  15219
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Wilkes Barre General Hospital Wilkes-Barre, Pennsylvania  18764
Roger Williams Medical Center/BUSM Providence, Rhode Island  02908-4735
CCOP - Greenville Greenville, South Carolina  29615
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Dixie Regional Medical Center Saint George, Utah  84770
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Virginia Mason Medical Center Seattle, Washington  98111
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center New York, New York  10032
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
CCOP - Oklahoma Tulsa, Oklahoma  74136
Comprehensive Cancer Institute of Huntsville Huntsville, Alabama  35801
Foundation for Cancer Research and Education Phoenix, Arizona  85013
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Bay Medical Center Panama City, Florida  32401
Tallahassee Memorial Healthcare Tallahassee, Florida  32308
Peninsula Regional Medical Center Salisbury, Maryland  21801
MidMichigan Medical Center - Midland Midland, Michigan  48670
William Beaumont Hospital Royal Oak, Michigan  48073
Nebraska Health System Omaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street Campus Elizabeth, New Jersey  07201
Monmouth Medical Center Long Branch, New Jersey  07740-6395
South Jersey Regional Cancer Center Millville, New Jersey  08332
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Atlantic City Medical Center Pomona, New Jersey  08240
Associated Radiologists, P.A. Warren, New Jersey  07059
St. Anthony Hospital Oklahoma City, Oklahoma  73101
St. John Health System Tulsa, Oklahoma  74104
University of Utah Health Sciences Center Salt Lake City, Utah  84132
Schiffler Cancer Center Wheeling, West Virginia  26003
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
James P. Wilmot Cancer Center Rochester, New York  14642
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
University of Tennessee Cancer Institute Memphis, Tennessee  38103
CCOP - Beaumont Royal Oak, Michigan  48073-6769
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
DCH Cancer Treatment Center Tuscaloosa, Alabama  35401
Sutter Health West Cancer Research Group Greenbrae, California  94904
Huntington Cancer Center Pasadena, California  91105
Robert and Beverly Lewis Family Cancer Care Center Pomona, California  91767
Radiation Medical Group, Incorporated San Diego, California  92101
Saint Mary's Hospital and Medical Center Grand Junction, Colorado  81502-1628
Hospital of St. Raphael New Haven, Connecticut  06511
Holmes Regional Medical Center Melbourne, Florida  32901-3276
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Clarian Health Partners Inc. Indianapolis, Indiana  46206-1367
Community Regional Cancer Care Indianapolis, Indiana  46219
Central Baptist Hospital Lexington, Kentucky  40503
William Beaumont Hospital - Troy Troy, Michigan  48098
Methodist Hospital Cancer Center - Omaha Omaha, Nebraska  68114
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly, New Jersey  08060
Valley Hospital Ridgewood, New Jersey  07450
Radiation Oncology Associates of Albuquerque Albuquerque, New Mexico  87109
Finger Lakes Radiation Oncology Center Clifton Springs, New York  14432
Vassar Brothers Medical Center Poughkeepsie, New York  12601
Riverhill Radiation Oncology Yonkers, New York  10701
Trinity Cancer Care Center Minot, North Dakota  58701
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Pocono Cancer Center East Stroudsburg, Pennsylvania  18301
York Cancer Center York, Pennsylvania  17403
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Latter Day Saints Hospital Salt Lake City, Utah  84143
RMH Regional Cancer Center Harrisonburg, Virginia  22801
Bon Secours - St. Mary's Hospital Richmond, Virginia  23226
All Saints Cancer Center Racine, Wisconsin  53405
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
Cancer Center at Lexington Clinic Lexington, Kentucky  40504
Abgenix Fremont, California  45267-0502
James P. Wilmot Cancer Center at the University of Rochester Medical Center Rochester, New York  14642