S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer

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

Sponsoren

Hauptsponsor: Southwest Oncology Group

Mitarbeiter: National Cancer Institute (NCI)

Quelle Southwest Oncology Group
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

- Induction therapy: 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.

Gesamtstatus Terminated
Anfangsdatum January 2003
Fertigstellungstermin May 2003
Primäres Abschlussdatum May 2003
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
overall survival up to 5 years
Sekundäres Ergebnis
Messen Zeitfenster
immune response at Week 10
toxicity assessment 22 weeks
response 25 weeks
Einschreibung 9
Bedingung
Intervention

Interventionsart: Biological

Interventionsname: monoclonal antibody 11D10 anti-idiotype vaccine

Armgruppenetikett: cisplatin and etoposide followed by vaccine

Interventionsart: Biological

Interventionsname: monoclonal antibody GD2 anti-idiotype vaccine

Armgruppenetikett: cisplatin and etoposide followed by vaccine

Interventionsart: Drug

Interventionsname: cisplatin

Armgruppenetikett: cisplatin and etoposide followed by vaccine

Interventionsart: Drug

Interventionsname: etoposide

Armgruppenetikett: cisplatin and etoposide followed by vaccine

Interventionsart: Radiation

Interventionsname: radiation therapy

Armgruppenetikett: cisplatin and etoposide followed by vaccine

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Abdul-Rahman Jazieh, MD, MPH Study Chair Barrett Cancer Center
Ort
Einrichtung:
MBCCOP - Gulf Coast | Mobile, Alabama, 36688, United States
CCOP - Greater Phoenix | 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, 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 AFB, 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
St. Louis University Health Sciences Center | Saint Louis, Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65807, 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
Standort Länder

Canada

United States

Überprüfungsdatum

June 2012

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: cisplatin and etoposide followed by vaccine

Art: Experimental

Beschreibung: standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov