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| ID | Type | Description | Link |
|---|---|---|---|
| S0122 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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Closed due to lack of drug availability.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cisplatin and etoposide followed by vaccine | Experimental | standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monoclonal antibody 11D10 anti-idiotype vaccine | Biological |
| ||
| monoclonal antibody GD2 anti-idiotype vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | time from date of registration to date of death | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| immune response | T-cell proliferation and HAMA testing | at Week 10 |
| toxicity assessment | assessment of qualitative and quantitative toxicities |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Abdul-Rahman Jazieh, MD, MPH | Barrett Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Gulf Coast | Mobile | Alabama | 36688 | United States | ||
| CCOP - Greater Phoenix |
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| Biological |
|
| cisplatin | Drug |
|
| etoposide | Drug |
|
| radiation therapy | Radiation |
|
| 22 weeks |
| response | RECIST partial and complete response | 25 weeks |
| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | 72205 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | 90073 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| University of Colorado Health Science Center | Aurora | Colorado | 80010-0510 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80010 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| MBCCOP - Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905-5650 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813-2424 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859-5000 | United States |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611-W227 | United States |
| MBCCOP - University of Illinois at Chicago | Chicago | Illinois | 60612-7323 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153-5500 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7353 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40502-2236 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130-3932 | United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71130 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | 02130 | United States |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0912 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Beaumont | Royal Oak | Michigan | 48073-6769 | United States |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | United States |
| Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | 39531-2410 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | 64128 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| St. Louis University Health Sciences Center | St Louis | Missouri | 63110 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | United States |
| Veterans Affairs Medical Center - Albany | Albany | New York | 12208 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Barrett Cancer Center | Cincinnati | Ohio | 45267-0501 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195-9001 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Kettering | Ohio | 45429 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97207 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97225 | United States |
| Oregon Cancer Institute | Portland | Oregon | 97239 | United States |
| Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | 29401-5799 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4095 | United States |
| Veterans Affairs Medical Center - Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7845 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78284 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98195-6527 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-5000 | United States |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
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