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L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases (LICC)

This study is currently recruiting participants.
Verified May 2013 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Dr. Carl Schimanski, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01462513
First received: October 27, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

Comparative evaluation of recurrence-free survival time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo vaccination and saline infusion.)


Condition Intervention Phase
Colon Carcinoma
Rectum Carcinoma
 Biological: L-BLP25
Biological: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: LICC: L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases - a Randomized, Placebo-controlled, Multicenter, Multinational, Double Blinded Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Comparative evaluation of recurrence-free survival time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo vaccination and saline infusion) [ Designated as safety issue: No ]
    The primary variable of this trial is recurrence free survival (RFS) time. RFS time will be measured from the date of randomization to the date of recurrence. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence will be calculated and used as a censored observation in the analysis.


Secondary Outcome Measures:
  • Overall survival time [ Designated as safety issue: No ]
    Overall survival (OS) time of all and of of MUC1 positive cancers, respectively, will be measured from the date of randomization to the date of death. For subjects not known to be deceased at the time of analysis, the time between the date of randomization and the date of last contact, or date lost to follow-up, will be calculated and used as a censored observation in the analysis.

  • Safety/tolerability [ Designated as safety issue: Yes ]

    Assessment of safety will include:

    • AEs, SAEs
    • Vital signs (body temperature, respiratory rate, heart rate, and blood pressure) and physical examinations,
    • Clinical laboratory assessments from hematology and biochemistry samples

  • Recurrence free survival time in a subgroup of MUC1 positive cancers [ Designated as safety issue: No ]
    Recurrence free survival (RFS) time of MUC1 positive cancers will be measured from the date of randomization to the date of relapse based on standard imaging. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence or death will be calculated and used as a censored observation in the analysis.

  • Overall survival time in a subgroup of MUC1 positive cancers [ Designated as safety issue: No ]
    Overall survival (OS) time of MUC1 positive cancers will be measured from the date of randomization to the date of death. For subjects not known to be deceased at the time of analysis, the time between the date of randomization and the date of last contact, or date lost to follow-up, will be calculated and used as a censored observation in the analysis.


Estimated Enrollment: 159
Study Start Date: August 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-BLP25
L-BLP25 vaccination
 Biological: L-BLP25
Vaccination 930µg per vaccination once weekly for 8 weeks, then at 6-week intervals during years 1 and 2, at 12-week intervals during year 3
Other Name: MUC1-antibody
Placebo Comparator: Placebo
Placebo
 Biological: Placebo
Vaccination: Placebo 930µg per vaccination, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2 and at 12-week intervals in year 3

Detailed Description:

This trial is designed for patients with metastatic colorectal carcinoma (CRC), who have undergone a complete resection of their primary tumor and recent resection of their liver metastases (R0 or R1) with curative intent. No generally accepted standard care is available following curative-intent resection of hepatic metastases in colorectal cancer patients. L-BLP25 is a cancer vaccine that targets MUC1, a well known tumor-associated antigen. Recently, it has been shown that MUC1 is associated with cellular transformation as demonstrated by tumorigenicity and can confer resistance to genotoxic agents. High levels of MUC1 cell surface expression, reported immunosuppressive activities of its released ectodomain, and anti-adhesive properties all contribute to the ability of the MUC1 antigen to protect and promote tumor cell growth and survival, and make MUC1 an attractive target for cancer immunotherapy.

Based on these results, L BLP25 may have potential as adjuvant therapy after curative resection of hepatic metastases in colorectal cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent.
  • Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to use an adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test is required for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of hormonal female contraceptive.
  • Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of local relapse.
  • Metastatic disease of the liver, with recent (< 8 weeks prior to randomization), both primary or secondary resection (R0 or R1) of all liver metastases. Metastasectomy may have been either synchronous or metachronous. Neoadjuvant therapy may have been applied prior to metastasectomy.
  • Subject has had a colonoscopy or rectoscopy within the last three months prior to initiation of therapy
  • Subject has an ECOG performance status of 0 or 1.
  • Subject has adequate hematologic, hepatic, and renal function within 2 weeks prior to initiation of therapy as defined by the following: Absolute neutrophils > 1,500/mm3 and platelets > 140,000/mm3. Bilirubin < 1.5 x upper limit of normal (ULN). AST and ALT < 2.5 x ULN. Creatinine < 1.5 x ULN. International Normalized Ratio (INR) and partial thromboplastin time (PTT) in the normal range of the local lab.
  • Willingness to comply with study protocol requirements.

Exclusion Criteria:

  • Metastases other than liver metastases.
  • R2 and Rx resected liver metastases. Patients with R1 resected liver metastases can be included if a further surgical resection is seen as not indicated or necessary in the surgeon´s opinion.
  • Chemotherapy within 4 weeks prior to randomization.
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, M- CSF], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
  • Any known autoimmune disease, past or current.
  • A recognized immunodeficiency disease including cellular immuno-deficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies.
  • Known or newly diagnosed active hepatitis B infection and/or hepatitis C infection, autoimmune hepatitis, known human immunodeficiency virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response, or expose him/ her to likelihood of more and/or severe side effects.
  • Past or current history of malignant neoplasm other than CRC, except for curatively treated non-melanoma skin cancer, in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
  • Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements.
  • Clinically significant cardiac disease, e.g. cardiac failure of New York Heart Association classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the previous 12 months as confirmed by an ECG.
  • Splenectomy.
  • Previous (less than 4 weeks prior to randomization) or concurrent treatment with a non-permitted drug.
  • Pregnancy and lactation period.
  • Participation in another clinical study within 30 days prior to randomization.
  • Known hypersensitivity to the study treatment drugs.
  • Known alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
  • Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462513

Locations
Austria
Salzburger Universitätsklinikum, Universitätsklinik für Innere Medizin III Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Prof. Dr.     +43 662 4482 2880     r.greil@salk.at    
Principal Investigator: Richard Greil, Prof. Dr.            
Sub-Investigator: Brigitte Mlineritsch, MD            
Germany
Klinikum Altenburger Land Not yet recruiting
Altenburg, Germany, 04600
Contact: Armin Schulz-Abelius, MD     0049 3447 52 ext 2353     Armin.Schulz-Abelius@Klinikum-Altenburgerland.de    
Contact: Janine Pohlmann     004903447 52 ext 1320     janine.pohlmann@klinikum-altenburgerland.de    
Principal Investigator: Armin Schulz-Abelius, MD            
Sub-Investigator: Jens Harms, PD MD            
Campus Virchow-Klinikum, Charite Centrum 8 Recruiting
Berlin, Germany, 13353
Contact: Daniel Seehofer, MD     +49 30450552001     daniel.seehofer@charite.de    
Principal Investigator: Daniel Seehofer, MD            
Sub-Investigator: Roberta Bova, MD            
Sub-Investigator: Dennis Eurich, MD            
Sub-Investigator: Wladimir Faber, MD            
Sub-Investigator: Anja Kießling, MD            
Klinikum Dortmund gGmbH, Medizinische Klinik Mitte Recruiting
Dortmund, Germany, 44137
Contact: Michael Heike, Prof. Dr.     +49 231 95321770     michael.heike@klinikumdo.de    
Principal Investigator: Michael Heike, Prof. Dr.            
Sub-Investigator: Sabine Bäumer, MD            
Sub-Investigator: Peter Boris Czyborra, MD            
Universitätsklinikum Essen WTZ-Ambulanz, Innere Medizin (Tumorforschung) Recruiting
Essen, Germany, 45122
Contact: Stefan Kasper, MD     +49 201 72385062     stefan.kasper@uk-essen.de    
Principal Investigator: Stefan Kasper, MD            
Sub-Investigator: Marit Ahrens, MD            
Sub-Investigator: Jörg Hense, MD            
Sub-Investigator: Mathias Hoiczyl, MD            
Sub-Investigator: Johannes Meiler, MD            
Sub-Investigator: Mareike Tometten, MD            
Sub-Investigator: Martin Schuler, MD            
Klinik für Allgemeine Innere Medizin, Onkologie / Hämatologie Recruiting
Esslingen, Germany, 73730
Contact: Michael Geißler, Prof. Dr.     0049 711 3103 ext 3232     m.geissler@klinikum-esslingen.de    
Contact: Stepanie Klink     0049 711 3103 ext 3232     s.klink@klinikum-esslingen.de    
Sub-Investigator: Jochen Bauer, MD            
Sub-Investigator: Fabienne Caime, MD            
Sub-Investigator: Hartmut Mahrhofer, MD            
Sub-Investigator: Rebekka Mannal, MD            
Sub-Investigator: Heike Mönnich, MD            
Sub-Investigator: Carsten Schwänen, PD MD            
Sub-Investigator: Swen Weßendorf, PD MD            
Principal Investigator: Michael Geißler, Prof. Dr.            
Klinikum der Johann W- Goethe Unversität, Klinik für Allgemein- und Viszeralchirurgie Recruiting
Frankfurt, Germany, 60590
Contact: Wolf O Bechstein, Professor     +49 69 63015251     wolf.bechstein@kgu.de    
Principal Investigator: Wolf O Bechstein, Professor            
Sub-Investigator: Christiane Gog, MD            
Sub-Investigator: Jörg Trojan, Professor            
Onkologische Schwerpunktpraxis Eppendorf Recruiting
Hamburg, Germany, 20249
Contact: Susanna Hegewisch-Becker, Prof. Dr.     +49 40 4602001     hegewisch@onkologie-eppendorf.de    
Principal Investigator: Susanna Hegewisch-Becker, Prof. Dr.            
Sub-Investigator: Thorsten Dierlamm, MD            
Städtisches Klinikium Abt. Allgemein- und Visceralchirurgie Recruiting
Karlsruhe, Germany, 76133
Contact: Michael Schön, Professor     +49 721 9742101     michael.schoen@klinikum-karlsruhe.de    
Principal Investigator: Michael Schön, Professor            
Sub-Investigator: Daniel Gärtner, MD            
Sub-Investigator: Monika Harbrecht-Hessle, MD            
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Florian Lordick, Prof. Dr     0049 341 97 ext 12560     florian.lordick@medizin.uni-leipzig.de    
Contact: Ulrich Meinel     0049 341 97 ext 12560     ulrich.meinel@medizin.uni-leipzig.de    
Principal Investigator: Florian Lordick, Prof. Dr            
Sub-Investigator: Dirk Forstmeyer, MD            
Universitätsklinikum Magdeburg Not yet recruiting
Magdeburg, Germany, 39120
Contact: Patrick Stübs, MD     0049 391 6715989     patrick.stuebs@med.ovgu.de    
Contact: Kathrin Zierau     0049 391 6715689     kathrin.zierau@med.ovgu.de    
Principal Investigator: Patrick Stübs, MD            
Sub-Investigator: Kerstein Schütte, MD            
Universitätsmedizin Mainz Recruiting
Mainz, Germany, 55131
Contact: Carl C Schimanski, MD     +49 6131 176076     schimanski@1-med.klinik.uni-mainz.de    
Contact: Markus Möhler, MD     +49 6131 175712     markus.moehler@unimedizin-mainz.de    
Principal Investigator: Carl C Schimanski, MD            
Sub-Investigator: Tina Friesing-Sosnik, MD            
Sub-Investigator: Markus Möhler, MD            
Sub-Investigator: Julia Sieg, MD            
Sub-Investigator: Daniel Foltys, MD            
Sub-Investigator: Marcus A. Wörns, MD            
Sub-Investigator: Michael Heise, MD            
Praxis für Hämatologie und Onkologie Recruiting
Mülheim an der Ruhr, Germany, 45468
Contact: Jan Schröder, PD Dr. med.     +49 208 76981     jan.schroeder@onkologie-mh.de    
Principal Investigator: Jan Schröder, PD Dr. med.            
Sub-Investigator: Katharina Sieg, MD            
Klinikum der Universität München-Grosshadern, Medizinische Klinik III Recruiting
München, Germany, 81377
Contact: Volker Heinemann, Professor     +49 89 70953019     Volker.Heinemann@med.uni-muenchen.de    
Principal Investigator: Volker Heinemann, Professor            
Sub-Investigator: Roswitha Forstpointer, MD            
Sub-Investigator: Clemens Gießen, MD            
Sub-Investigator: Dominik Modest, MD            
Sub-Investigator: Sebastian Stinzing, MD            
GP für Hämatologie und Onkologie Offenburg Recruiting
Offenburg, Germany, 77654
Contact: Bernhard Linz, MD     +49 781 9705779     linz@onkologie-offenburg.de    
Principal Investigator: Bernhard Linz, MD            
Sub-Investigator: Andreas Jakob, MD            
Sub-Investigator: Marianne Müller, MD            
Oncologianova GmbH Recruiting
Recklinghausen, Germany, 45657
Contact: Friedrich Overkamp, MD     +49 2361 90427 23     overkamp@onkologie-re.de    
Principal Investigator: Friedrich Overkamp, MD            
Sub-Investigator: Ludger Heflik, MD            
Sub-Investigator: Till-Oliver Emde            
Robert-Bosch Krankenhaus, Zentrum für Innere Medizin Recruiting
Stuttgart, Germany, 70376
Contact: Matthias Vöhringer, MD     +49 711 81013506     matthias.voehringer@rbk.de    
Principal Investigator: Matthias Vöhringer, MD            
Sub-Investigator: Walter-Erich Aulitzky, Professor            
Sub-Investigator: Liza Bacchus-Gerybadze, MD            
Sub-Investigator: Martin Kaufmann, MD            
Sub-Investigator: Sonja Martin, MD            
Sub-Investigator: Annette Steckkönig, MD            
Klinikum Weiden, Medizinische Klinik I Recruiting
Weiden, Germany, 92637
Contact: Frank Kullmann, Professor     +49 961 3033114     frank.kullmann@kliniken-nordoberpfalz.ag    
Principal Investigator: Frank Kullmann, Professor            
Sub-Investigator: Armin Leitner, MD            
Sub-Investigator: Holger Tuchbreiter, MD            
Sponsors and Collaborators
Dr. Carl Schimanski
Investigators
Principal Investigator: Carl Christoph Schimanski, MD Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Dr. Carl Schimanski, Coordinating Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01462513     History of Changes
Other Study ID Numbers: LICC01
Study First Received: October 27, 2011
Last Updated: May 6, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Federal Office for Safety in Health Care

Keywords provided by Johannes Gutenberg University Mainz:
Colon carcinoma
Rectum carcinoma
Liver metastases

Additional relevant MeSH terms:
Carcinoma
Rectal Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013