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Cancer Vaccine Study for Unresectable Stage III Non-Small Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


Pharmaceutical / Industry


EMR 63325-001
NCT00409188

Trial Description

Summary

The purpose of this study is to determine whether the cancer vaccine Stimuvax in addition to best supportive care is effective in prolonging the lives of patients with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

Further Study Information

To Be Determined

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically documented unresectable stage III NSCLC.
  • Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks(28 days) prior to randomization.
  • Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of ≥ 50 Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible.
  • Geographically accessible for ongoing follow-up, and committed to comply with the designated visits.
  • An ECOG performance status of 0-1.

Exclusion Criteria:

  • Pre-Therapies:
  • Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy.
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
  • Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization.
  • Disease Status:
  • Metastatic disease
  • Malignant pleural effusion at initial diagnosis and at study entry.
  • Past or current history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
  • Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study.
  • A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies.
  • Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).
  • Known Hepatitis B and/or C.
  • Physiological Functions:
  • Clinically significant hepatic dysfunction.
  • Clinically significant renal dysfunction.
  • Clinically significant cardiac disease.
  • Splenectomy.
  • Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response.
  • Standard Safety:
  • Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator.
  • Known drug abuse/alcohol abuse.
  • Legal incapacity or limited legal capacity

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

EMD Serono, Incorporated

Frances Shepherd, MD, FRCPCPrincipal Investigator

Merck KGaA Communication CenterPh: 0049 6151 72 5200
  Email: service@merck.de

Emerging Med - North AmericaPh: 1-800-507-5284

Trial Sites

U.S.A.
Arizona
  Glendale
 Research Site
Arkansas
  Fort Smith
 Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
 Teresa Madden Ph: 479-314-1709
  Email: teresa.madden@mercy.net
California
  Anaheim
 Pacific Cancer Medical Center, Incorporated
 Javier Zuniga Ph: 714-999-1465 Ext.209
  Email: javierz@pacificcancer.com
  Duarte
 Research Site
  Glendale
 Glendale Adventist Medical Center
 Maria Brown Ph: 818-409-6687
  Email: brownmt@ah.org
  Los Angeles
 Norris Cancer Hospital
 Shirley Sian Ph: 323-865-0591
  Email: sian_s@ccnt.hsc.usc.edu
  Montebello
 Clinical Trials and Research Associates, Incorporated
 Sulema Murillo Ph: 323-724-8769
  Email: smurillo@beverlyoncology.com
  Orange
 Medical Oncology Care Associates - Orange
 Lorraine Skeers Ph: 714-541-6622
  Email: research@medicaloncologycare.com
  Stockton
 Stockton Hematology Oncology Medical Group, Inc.
 Yvonne Bossert Ph: 209-466-2626
  Email: ybossert@msn.com
Florida
  Brooksville
 Pasco Hernando Oncology Associates, PA - Brooksville
 Kim Graves Ph: 352-596-1401 Ext.218
  Email: kgraves@phoa4.com
  New Port Richey
 Pasco Hernando Oncology Associates, PA - New Port Richey
 Sissi Hethershaw Ph: 727-842-2795
  Email: shethershaw@phoa4.com
  Ormond Beach
 Florida Hospital Cancer Institute - Ormond Beach
 Sandy Alonso Ph: 386-676-6270
  Email: sandra.alonso2@fhms.org
  Port Saint Lucie
 Treasure Coast Cancer Care Center
 Ram Ravipati Ph: 772-398-6016
  Email: tcccc@bellsouth.net
  Vero Beach
 Vero Beach Hematology Oncology, PA
 Madhusudan Soni Ph: 772-299-4255
  Email: sonim@bellsouth.net
Georgia
  Atlanta
 Georgia Cancer Specialists - Northside Office
 Christopher Moore Ph: 770-496-9427
  Email: christopher.moore@gacancer.com
  Decatur
 Research Site
Hawaii
  Honolulu
 Straub Clinic and Hospital, Incorporated
 Felix Militante Ph: 808-522-4536
  Email: felix.militante@wilcoxhealth.org
Illinois
  Centralia
 Southern Illinois Hematology/Oncology
 Lynn Ann Waggoner-Pigg Ph: 618-533-5000
  Email: lynnannwag@charter.net
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Maureen Clennon Ph: 815-730-3098
  Email: maureenc@jolietoncology.com
Iowa
  Waterloo
 Covenant Clinic
 Wendy Gibbs Ph: 319-272-2070
  Email: wendy.gibbs@wfhc.org
Kentucky
  Hazard
 Kentucky Cancer Center
 Janie Chapman Ph: 606-439-2239
  Email: jchapmanis1@hotmail.com
Louisiana
  Metarie
 Hematology and Oncology Specialists, LLC - Metairie
 Mary Ann Ostroske Ph: 504-669-5987
  Email: mostroske1@salco.net
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Jennifer Hertsch Ph: 410-601-9083
  Email: jhertsch@lifebridgehealth.org
  Prince Frederick
 Calvert Memorial Hospital
 Sarah Sherman-VanDeventer Ph: 410-414-4658
  Email: ssherman@cmhlink.org
Michigan
  Saint Joseph
 Oncology Care Associates, PLLC
 Kathy Estkowski Ph: 269-985-0029 Ext.181
  Email: kathyestkowski@oncology-care.com
Minnesota
  Minneapolis
 University of Minnesota Physicians, Masonic Cancer Center
 Melissa Spence Ph: 612-625-0673
  Email: spenc206@umn.edu
Missouri
  Saint Louis
 Research Site
Montana
  Billings
 Billings Clinic Cancer Center
 Sunny Park Ph: 406-238-2647
  Email: spark@billingsclinic.org
  Great Falls
 Big Sky Oncology
 Deanna Harrer Ph: 406-731-8217
  Email: harrerdp@benefis.net
Nebraska
  Hastings
 Nebraska Cancer Care, LLC
 Carlene Springer Ph: 402-460-5899
  Email: carlene@nebraskacancercare.com
  Lincoln
 Southeast Nebraska Cancer Center
 Tracy Christianson Ph: 402-420-7000 Ext.130
  Email: tracyc@senhoc.com
Nevada
  Las Vegas
 Nevada Cancer Institute
 Alina Fries Ph: 702-822-5346
  Email: afries@nvcancer.org
New Jersey
  Flemington
 Hunterdon Regional Cancer Center at Hunterdon Medical Center
 Lynda Poff Ph: 908-237-2330 Ext.4
  Email: poff.lynda@hunterdonhealthcare.org
New York
  New City
 Hematology-Oncology Associates of Rockland, PC
 Martha Brahms Ph: 845-362-1750
  Email: mbrahms2@rocklandhemonc.com
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Tammy Allred Ph: 919-966-4432
  Email: tammy_allred@med.unc.edu
  Wilmington
 Hanover Medical Specialts PA
 Karen Kass Ph: 910-362-4226
  Email: kkass@hmsdocs.com
Ohio
  Canton
 Gabrail Cancer Center - Canton Office
 Carrie Smith Ph: 330-492-3345 Ext.208
  Email: csmith@gabrailcancercenter.com
  Cleveland
 Case Comprehensive Cancer Center
 Rody Olmstead Ph: 216-844-8988
  Middletown
 Signal Point Hematology Oncology Incorporated
 Susan Smith Ph: 513-423-0504
  Email: susan_smith@swohio.twcbc.com
  Zanesville
 Oncology Hematology Consultants of SEO, Inc.
 Wendy Long Ph: 740-454-5232
  Email: wlong@genesishcs.org
Oregon
  Portland
 Providence Portland Medical Center
 Brenda Fisher Ph: 503-215-2613
  Email: brenda.fisher@providence.org
Pennsylvania
  Altoona
 Blair Medical Associates at Station Medical Center
 Julia Benton Ph: 814-946-7569
  Email: jbenton@bma.md
  Gettysburg
 Gettysburg Cancer Center
 Elizabeth Shultz Ph: 717-334-4033
  Email: elizabeth@gettysburgoncology.com
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Holly McConville Ph: 215-615-1663
  Email: holly.mcconville@uphs.upenn.edu
South Carolina
  Spartanburg
 Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center
 Bruce Grant Ph: 864-560-1841
  Email: bgrant@srhs.com
Tennessee
  Germantown
 Jones Clinic - Germantown
 Lori Lynch Ph: 901-685-5969 Ext.322
  Email: llynch@jonescancerclinic.com
Texas
  Dallas
 Center for Oncology Research
 Stacey Beasley Ph: 972-566-4175
  Email: stbeasley@cortaa.com
  Fort Worth
 Center for Cancer and Blood Disorders - Fort Worth
 Julie Weikel Ph: 817-759-7023
  Email: jweikel@txcc.com
 John Peter Smith Center for Cancer Care
 Celeste Caliman Ph: 817-852-8302
  Email: ccaliman@jpshealth.org
  Houston
 Research Site
Virginia
  Fairfax
 Fairfax Northern Virginia Hematology Oncology, PC - Fairfax
 Ellen Ritter Ph: 703-208-9258
  Email: ellen.ritter@usoncology.com
Washington
  Seattle
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 David Landes Ph: 206-386-2301
  Email: david.landes@swedish.org
West Virginia
  Wheeling
 Wheeling Hospital
 Carla Pahlrn Ph: 304-243-6442
  Email: cpahl@wheelinghospital.org
Argentina
  Bahia Blanca
 Research Site
  Cuidad Autónoma de Buenos Aires
 Research Site
  Rosario
 Research Site
  San Martin
 Research Site
  Tandil
 Research Site
Australia
  Camperdown
 Research Site
  Heidelberg
 Research Site
  Kingswood
 Research Site
  Nedlands
 Research Site
  Saint Leonards
 Research Site
  Woolloongabba
 Research Site
South Australia
  Toorak Gardens
 Research Site
Austria
  Graz
 Research Site
  Salzburg
 Research Site
  Wels
 Research Site
  Wien
 Research Site
Belgium
  Bruxelles
 Research Site
  Leuven
 Research Site
  Mechelen
 Research Site
  Yvoir
 Research Site
Canada
  Calgary
 Research Site
  Greenfield Park
 Research Site
  Hamilton
 Research Site
  Montreal
 Research Site
  Sainte-Foy
 Research Site
  Surrey
 Research Site
  Thunder Bay
 Research Site
  Toronto
 Research Site
  Vancouver
 Research Site
  Victoria
 Research Site
  Windsor
 Research Site
  Winnipeg
 Research Site
Nova Scotia
  Halifax
 Research Site
Ontario
  Sault Sainte Marie
 Research Site
Czech Republic
  Ostrava-Poruba
 Research Site
  Prague
 Research Site
  Praha
 Research Site
Denmark
  Herlev
 Research Site
  Odense C
 Research Site
France
  Marseille
 Research Site
  Nancy
 Research Site
  Paris Cedex 15
 Research Site
  Strasbourg Cedex
 Research Site
Germany
  Berlin
 Research Site
  Coswig
 Research Site
  Essen
 Research Site
  Frankfurt
 Research Site
  Frankfurt am Main
 Research Site
  Freiburg
 Research Site
  Gauting
 Research Site
  Goslar
 Research Site
  Großhansdorf
 Research Site
  Heidelberg
 Reseach Site
  Homburg
 Research Site
  Karlsruhe
 Research Site
  Kassel
 Research Site
  Koln
 Research Site
  Leipzig
 Research Site
  Magdeburg
 Research Site
  Mainz
 Research Site
  Minden
 Research Site
  München
 Research Site
  Oldenburg
 Research Site
  Rostock
 Research Site
Greece
  Thessaloniki
 Research Site
Hong Kong
  Hong Kong
 Research Site
  Shatin
 Research Site
Hungary
  Budapest
 Research Site
  Mátraháza
 Research Site
  Nyíregyháza
 Research Site
  Szombathely
 Research Site
  Tatabayana
 Research Site
India
  Chennai
 Research Site
  Hyderabad
 Research Site
  Mumbai
 Research Site
  Vellore
 Research Site
Ireland
  Dublin
 Research Site
  Galway
 Research Site
Italy
  Brescla
 Research Site
  Meldola
 Research Site
Mexico
  Hermosillo
 Research Site
  Morella, Michoacan
 Research Site
Netherlands
  Tilburg
 Research Site
  Zwolle
 Research Site
Poland
  Bialystok
 Research Site
  Bydgoszcz
 Research Site
  Bytom
 Research Site
  Gdynia
 Research Site
  Kraków
 Research Site
  Olsztyn
 Research Site
  Otwock
 Research Site
  Poznan
 Research Site
  Torun
 Research Site
  Warsaw
 Research Site
  Warszawa
 Genova
  Wroclaw
 Research Site
  Zabrze
 Research Site
Portugal
  Porto
 Genova
Republic of Singapore
  Singapore
 Research Site
Romania
  Bucharest
 Research Site
  Cluj-Napoca
 Research Site
  Iasi
 Research Site
  Suceava
 Research Site
Russia
  Barnaul
 Research Site
  Chelaybinsk
 Genova
  Ivanovo
 Research Site
  Kazan
 Research Site
  Tomsk
 Research Site
  Voronezh
 Research Site
  Yaroslavl
 Research Site
Spain
  Burgos
 Research Site
  Donostia-San Sebastian
 Research Site
  Malaga
 Research Site
  San Sebastian
 Research Site
Sweden
  Gävle
 Research Site
  Göteborg
 Research Site
  Lund
 Research Site
  Stockholm
 Research Site
  Umea
 Research Site
  Uppsala
 Research Site
Switzerland
  Basel
 Research Site
  Geneve
 Research Site
  Winterthur
 Research Site
Taiwan, Province of China
  Taichung
 Research Site
  Tainan
 Research Site
  Taipei
 Research Site
  Tao-Yuan
 Research Site
United Kingdom
  Cheltnam
 Research Site
  Cornwall
 Research Site
  Edinburgh
 Research Site
  Manchester
 Research Site
  Torquay
 Research Site
  Wirral
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00409188
Information obtained from ClinicalTrials.gov on July 24, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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