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Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer. Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the efficacy of cisplatin, etoposide, and thoracic radiotherapy followed by cisplatin, etoposide, monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), and monoclonal antibody GD2 anti-idiotype vaccine (TriGem), in terms of overall and progression-free survival of patients with limited stage small cell lung cancer. - Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients. - Determine the qualitative and quantitative toxicity of this regimen in these patients. - Determine the response rates (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen. OUTLINE: This is a multicenter study. - Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Thoracic radiotherapy is administered 5 days a week, beginning on day 1 of chemotherapy, for 5 weeks. Patients then undergo radiotherapy boost for 1.5 weeks. Patients with stable disease or at least partial response proceed to consolidation therapy. - Consolidation therapy (begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy): Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine (TriAb) and monoclonal antibody GD2 anti-idiotype vaccine (TriGem) intradermally on day 1 of weeks 11, 13, 15, and 17 (4 injections) and then monthly subcutaneously for 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after consolidation chemotherapy undergo cranial radiotherapy 5 days a week for 3 weeks. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Abdul-RahmanJazieh, Study Chair, Barrett Cancer Center
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of Washington School of Medicine
Seattle, Washington, 98195-6527
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Colorado Health Science Center
Aurora, Colorado, 80010-0510
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
CCOP - Columbia River Program
Portland, Oregon, 97225
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Additional Information:
Study ID Numbers: CDR0000256922; SWOG-S0122
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045617
Other Limited Stage Small Cell Lung Cancer Studies:
1. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
2. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
3. Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
4. Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
5. Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Illinois Clinical Trials
Other Hines Clinical Trials
Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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