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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045617 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: monoclonal antibody 11D10 anti-idiotype vaccine Biological: monoclonal antibody GD2 anti-idiotype vaccine Drug: cisplatin Drug: etoposide Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with stable disease or at least partial response proceed to consolidation therapy.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock (McClellan) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| University of Colorado Health Science Center | |
| Aurora, Colorado, United States, 80010-0510 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813-2424 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-W227 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Biloxi | |
| Biloxi, Mississippi, United States, 39531-2410 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| United States, Oklahoma | |
| Oklahoma Medical Research Foundation | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97225 | |
| Oregon Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4095 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7845 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Veterans Affairs Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78284 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195-6527 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Study Chair: | Abdul-Rahman Jazieh, MD, MPH | Barrett Cancer Center |
More Information
| Study ID Numbers: | CDR0000256922, SWOG-S0122 |
| Study First Received: | September 6, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00045617 History of Changes |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Immunoglobulin Idiotypes Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Etoposide phosphate Antibodies, Monoclonal Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Etoposide Immunoglobulins Respiratory Tract Neoplasms Neoplasms by Histologic Type Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Antibodies Radiation-Sensitizing Agents Lung Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic |