S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC) Evidence of disease by CT scan of the chest Measurable or evaluable disease outside of area of prior surgical resection No malignant pericardial or pleural effusions (cytologically positive effusions or exudative effusions not attributable to other etiologies) No CNS disease by chest CT scan or MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Not specified Renal Creatinine no greater than upper limit of normal OR Creatinine clearance at least 60 mL/min Other No prior hypersensitivity or contraindication to monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), monoclonal antibody GD2 anti-idiotype vaccine (TriGem), or aluminum hydroxide No known sensitivity to rodent proteins (i.e., anti-OKT-3, ONCOSCINT scan) No grade 1 or greater symptomatic sensory neuropathy No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease free for 5 years If significant clinical hearing loss already present, must accept risk of further hearing loss Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for SCLC No prior TriAb or TriGem No prior murine antibodies No prior mouse proteins At least 30 days since prior immunotherapy At least 30 days since any prior immunization Chemotherapy No prior systemic chemotherapy for SCLC No concurrent cyclophosphamide or methotrexate Endocrine therapy At least 30 days since prior systemic corticosteroids No concurrent systemic corticosteroids (except as an antiemetic) Radiotherapy No prior radiotherapy to the thorax or neck region No concurrent intensity modulated radiotherapy Surgery See Disease Characteristics At least 2 weeks since prior thoracic or other major surgery and recovered Other At least 30 days since prior investigational agents or devices No other concurrent investigational agents No other concurrent immunosuppressants (e.g., cyclosporine) No concurrent chronic systemic antihistamines No concurrent amifostine
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Health Science Center
- University of Colorado Cancer Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- Tripler Army Medical Center
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Medical Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Hospital - Southfield
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Albany
- Herbert Irving Comprehensive Cancer Center
- University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Barrett Cancer Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- Oregon Cancer Institute
- Veterans Affairs Medical Center - Charleston
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Veterans Affairs Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- University of Washington School of Medicine
- CCOP - Northwest
- Madigan Army Medical Center
- British Columbia Cancer Agency
Arms of the Study
Arm 1
Experimental
cisplatin and etoposide followed by vaccine
standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine