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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Carl Schimanski, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01462513
First received: October 27, 2011
Last updated: July 13, 2015
Last verified: July 2015
  Purpose

Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo 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

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo 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:
  • 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 the 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 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.


Enrollment: 122
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-BLP25
L-BLP25 treatment
Biological: L-BLP25
Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.
Other Name: MUC1-antibody
Placebo Comparator: Placebo
Placebo
Biological: Placebo
Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.

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) within normal range respectively within therapeutic range in case of anticoagulation.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462513

Locations
Austria
Salzburger Universitätsklinikum, Universitätsklinik für Innere Medizin III
Salzburg, Austria, 5020
Germany
Klinikum Altenburger Land
Altenburg, Germany, 04600
Campus Virchow-Klinikum, Charite Centrum 8
Berlin, Germany, 13353
Klinikum Darmstadt
Darmstadt, Germany, 64283
Universitätsklinikum Essen WTZ-Ambulanz, Innere Medizin (Tumorforschung)
Essen, Germany, 45122
Klinik für Allgemeine Innere Medizin, Onkologie / Hämatologie
Esslingen, Germany, 73730
Klinikum der Johann W- Goethe Unversität, Klinik für Allgemein- und Viszeralchirurgie
Frankfurt, Germany, 60590
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, Germany, 20249
Städtisches Klinikium Abt. Allgemein- und Visceralchirurgie
Karlsruhe, Germany, 76133
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Universitätsmedizin Mainz
Mainz, Germany, 55131
Universtitäsmedizin Gießen und Marburg
Marburg, Germany, 35033
Praxis für Hämatologie und Onkologie
Mülheim an der Ruhr, Germany, 45468
Klinikum der Universität München-Grosshadern, Medizinische Klinik III
München, Germany, 81377
GP für Hämatologie und Onkologie Offenburg
Offenburg, Germany, 77654
Oncologianova GmbH
Recklinghausen, Germany, 45657
Universitätsklinikum Regensburg
Regensburg, Germany, 93042
Robert-Bosch Krankenhaus, Zentrum für Innere Medizin
Stuttgart, Germany, 70376
Krankenhaus der Barmherzigen Brüder
Trier, Germany, 54292
Klinikum Weiden, Medizinische Klinik I
Weiden, Germany, 92637
Sponsors and Collaborators
Prof. Dr. Carl Schimanski
Investigators
Principal Investigator: Carl Christoph Schimanski, Prof. Dr. Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Prof. 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: July 13, 2015
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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 31, 2015