Lung Cancer Clinical Trial
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
Full Description
OBJECTIVES:
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 cancer.
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 regimen.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Zubrod 0-1
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Not specified
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min
Cardiovascular:
No superior vena cava syndrome
Pulmonary:
FEV_1 at least 1.0 L
Gastrointestinal:
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 years
Other:
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 hospitalization
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
PRIOR CONCURRENT THERAPY:
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 therapy
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
Chemotherapy:
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
Radiotherapy:
No prior thoracic radiotherapy
Surgery:
See Disease Characteristics
Other:
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
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There are 229 Locations for this study
Birmingham Alabama, 35294, United States
Huntsville Alabama, 35801, United States
Huntsville Alabama, 35807, United States
Mobile Alabama, 36688, United States
Montgomery Alabama, 36106, United States
Tuscaloosa Alabama, 35401, United States
Phoenix Arizona, 85013, United States
Concord California, 94524, United States
Duarte California, 91010, United States
Fremont California, 45267, United States
Fresno California, 93720, United States
Fresno California, 93729, United States
Greenbrae California, 94904, United States
Loma Linda California, 92354, United States
Long Beach California, 90822, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
Oakland California, 94609, United States
Pasadena California, 91105, United States
Pomona California, 91767, United States
Sacramento California, 95816, United States
San Diego California, 92101, United States
San Francisco California, 94143, United States
San Jose California, 95128, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80010, United States
Denver Colorado, 80224, United States
Grand Junction Colorado, 81502, United States
New Haven Connecticut, 06511, United States
Newark Delaware, 19713, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Melbourne Florida, 32901, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33125, United States
Miami Florida, 33136, United States
Miami Florida, 33256, United States
Orlando Florida, 32806, United States
Panama City Florida, 32401, United States
Panama City Florida, 32405, United States
Sarasota Florida, 34233, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Columbus Georgia, 31901, United States
Rome Georgia, 30165, United States
Honolulu Hawaii, 96813, United States
Arlington Heights Illinois, 60005, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61636, United States
Anderson Indiana, 46016, United States
Bloomington Indiana, 47402, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46206, United States
Indianapolis Indiana, 46219, United States
Muncie Indiana, 47303, United States
South Bend Indiana, 46601, United States
Dubuque Iowa, 52001, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40504, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40215, United States
Madisonville Kentucky, 42431, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Portland Maine, 04102, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21231, United States
Salisbury Maryland, 21801, United States
Boston Massachusetts, 02115, United States
Hyannis Massachusetts, 02601, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Kalamazoo Michigan, 49007, United States
Marquette Michigan, 49855, United States
Midland Michigan, 48670, United States
Royal Oak Michigan, 48073, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48098, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63108, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
East Orange New Jersey, 07019, United States
Edison New Jersey, 08818, United States
Elizabeth New Jersey, 07201, United States
Long Branch New Jersey, 07740, United States
Millville New Jersey, 08332, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 38103, United States
Newark New Jersey, 07112, United States
Pomona New Jersey, 08240, United States
Ridgewood New Jersey, 07450, United States
Toms River New Jersey, 08755, United States
Trenton New Jersey, 08629, United States
Warren New Jersey, 07059, United States
Albuquerque New Mexico, 87109, United States
Albany New York, 12208, United States
Brooklyn New York, 11203, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14263, United States
Clifton Springs New York, 14432, United States
Manhasset New York, 11030, United States
New York New York, 10032, United States
Plattsburgh New York, 12901, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Rochester New York, 14642, United States
Syracuse New York, 13217, United States
Yonkers New York, 10701, United States
Chapel Hill North Carolina, 27599, United States
Concord North Carolina, 28025, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Minot North Dakota, 58701, United States
Akron Ohio, 44302, United States
Akron Ohio, 44304, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Columbus Ohio, 43210, United States
Dayton Ohio, 45429, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73101, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74104, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97225, United States
Allentown Pennsylvania, 18105, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Darby Pennsylvania, 19023, United States
Drexel Hill Pennsylvania, 19026, United States
East Stroudsburg Pennsylvania, 18301, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15219, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15236, United States
Reading Pennsylvania, 19612, United States
Scranton Pennsylvania, 18501, United States
Wilkes-Barre Pennsylvania, 18764, United States
York Pennsylvania, 17403, United States
Providence Rhode Island, 02908, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57709, United States
Jackson Tennessee, 38301, United States
Memphis Tennessee, 38103, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
Lubbock Texas, 79410, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84132, United States
Salt Lake City Utah, 84143, United States
Burlington Vermont, 05405, United States
Charlottesville Virginia, 22908, United States
Harrisonburg Virginia, 22801, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98111, United States
Spokane Washington, 99204, United States
Yakima Washington, 98902, United States
Wheeling West Virginia, 26003, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53713, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Racine Wisconsin, 53405, United States
Waukesha Wisconsin, 53188, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Saint John New Brunswick, E2L 4, Canada
St. Johns Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 1, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7A 7, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Fleurimont Quebec, J1H 5, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2W 1, Canada
Quebec City Quebec, G1R 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
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