Trial record 11 of 149 for:    Open Studies | "Urinary Bladder Neoplasms"

Clinical Study to Evaluate the Safety and Efficacy of recMAGE-A3 + AS-15 in Patients From Which the Bladder is Removed Due to Muscle Invasive Bladder Cancer (MAGNOLIA)

This study is currently recruiting participants.
Verified September 2011 by European Association of Urology Research Foundation
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
European Association of Urology Research Foundation
ClinicalTrials.gov Identifier:
NCT01435356
First received: September 2, 2011
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections will be administered over 27 months.


Condition Intervention Phase
Urinary Bladder Neoplasms
Biological: recMAGE-A3 + AS15 ASCI
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo Controlled Phase II Trial to Evaluate the Safety and Efficacy of recMAGE-A3 + AS15 ASCI in Patients With MAGE-A3 Positive Muscle Invasive Bladder Cancer After Cystectomy

Resource links provided by NLM:


Further study details as provided by European Association of Urology Research Foundation:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluation of the clinical efficacy in terms of Disease Free Survival of treatment versus placebo in patients with bladder cancer with MAGE-A3 expression after cystectomy


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival

  • Disease-free specific survival (DFSS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Disease-free specific survival (DFSS)

  • Distant metastasis-free survival (DMFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Distant metastasis-free survival (DMFS)

  • (Serious) Adverse events [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Safety of recMAGE-A3 + AS15 ASCI

  • Translational research on gene signature and expression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluation of the tumoral gene expression profiles by microarray analysis on total mRNA extracts from the primary tumor

  • Immune response to recMAGE-A3 + AS15 ASCI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluation of the immune response by measuring titers of antibodies in serum against recMAGE-A3+AS15 ASCI

  • Translational research on gene signature and expression [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Evaluate whether a predefined set of genes expressed by the tumor might be predictive to treatment efficacy in terms of disease free survival and overall survival.


Estimated Enrollment: 273
Study Start Date: August 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: recMage-A3 + AS15 ASCI
MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI
Biological: recMAGE-A3 + AS15 ASCI
5 doses will be administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
Placebo Comparator: Placebo Biological: Placebo
5 doses will be administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months

  Eligibility

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

Inclusion Criteria:

  1. Aged greater than or equal to 18 years at the time ICF is signed, either sex.
  2. Histologically confirmed (after cystectomy) transitional cell carcinoma of bladder urothelium which is MAGE-A3 positive.
  3. Written informed consent for tissue and (optional) urine sampling, MAGE-A3 expression analysis and gene profiling and optional translational research has been obtained from the patient prior to cystectomy, and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
  4. TNM classification at pathological examination of surgically removed specimen: Stage T2,3 N0 or N1 or N2 and M0 disease or Stage T4 N0 M0 disease. (TNM classification)
  5. The patient is free of residual disease and free of metastasis, as confirmed by a negative baseline Computer Tomogram (CT scan) or Magnetic Resonance Imaging (MRI) of the pelvis, abdomen and chest no more than 9 weeks prior to randomization. Other examinations should be performed as clinically indicated.
  6. Patient is fully recovered from surgery within 9 weeks following cystectomy.
  7. The patient must have adequate bone-marrow reserve, defined as an absolute neutrophil count ≥ 1.0 x 109/L, and a platelet count ≥ 75 x 109/L, adequate renal function, defined as a serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN), and adequate hepatic function, defined as a Total bilirubin ≤ 1.5 times the ULN, and a Alanine transaminase (ALAT) and Aspartate Transaminase (ASAT) ≤ 2.5 times the ULN as assessed by standard laboratory criteria.
  8. World Health Organization (WHO) performance status 0 - 1 at the time of randomization.
  9. If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.

Exclusion Criteria:

  1. The patient has previous or concomitant malignancies at other sites except effectively treated non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years.
  2. The patient has received any anti cancer systemic treatment, including immunotherapy (local intravesical BCG is allowed), chemotherapy, or neo-adjuvant chemotherapy, except: For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years).
  3. The patient has received radiotherapy of the abdominal or pelvic region, within 6 months prior to randomization.
  4. Women who are pregnant or breast feeding.
  5. The patient has a known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C.
  6. The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  7. The patient has any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases. Patients with vitiligo are not excluded to participate in the trial.
  8. Patient has received a major organ allograft.
  9. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. Note: the use of prednisone, or equivalent, < 0,125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted.
  10. The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study.
  11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
  12. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. For example, but not limited to: uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary heart disease or myocardial infarction) or uncontrolled arrhythmia.
  13. The patient uses alternative treatments eg. plantextracts.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435356

Contacts
Contact: Wanda M. de Raadt, MSc +31263890677 w.deraadt@uroweb.org
Contact: Wim PJ Witjes, PhD +31263890677 w.witjes@uroweb.org

Locations
France
Groupe hospitalier Pellegrin Not yet recruiting
Bordeaux, France
Institut Bergonié Not yet recruiting
Bordeaux, France
Hôpital Huriez Not yet recruiting
Lille, France
Hôpital Edouard Herriot Not yet recruiting
Lyon, France
Institut Curie Not yet recruiting
Paris, France
Hôpital Rangueil Not yet recruiting
Toulouse, France
Germany
Universitätsklinikum Aachen Not yet recruiting
Aachen, Germany
Heinrich-Heine University Not yet recruiting
Duesseldorf, Germany
Universitätsklinikum Giessen Not yet recruiting
Giessen, Germany
Universitätsklinikum Jena Recruiting
Jena, Germany
Universität Kiel Not yet recruiting
Kiel, Germany
Universitätsklinikum Marburg Not yet recruiting
Marburg, Germany
Universitätsklinikum Tuebingen Not yet recruiting
Tuebingen, Germany
Italy
Universitaria Policlinico Consorziale di Bari Not yet recruiting
Bari, Italy
Università degli Studi Not yet recruiting
Chieti, Italy
Università Vita e Saluta Not yet recruiting
Milano, Italy
Ospedaliera di Perugia Not yet recruiting
Perugia, Italy
Universitaria Pisana Not yet recruiting
Pisa, Italy
Università di Roma, La Sapienza Not yet recruiting
Rome, Italy
Netherlands
St Antoniusziekenhuis Not yet recruiting
Nieuwegein, Netherlands
UMC St Radboud Not yet recruiting
Nijmegen, Netherlands
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Spain
Hospital Universitario A Coruña Not yet recruiting
A Coruña, Spain
Hospital Universitario Principe de Asturias Not yet recruiting
Alcalá de Henares, Spain
Hospital Universitario Fundación Alcorcón Not yet recruiting
Alcorcón, Spain
Hospital del Mar Not yet recruiting
Barcelona, Spain
Hospital Clinic Barcelona Not yet recruiting
Barcelona, Spain
Fundación Puigvert Not yet recruiting
Barcelona, Spain
Hospital Universitario Puerta del Mar Not yet recruiting
Cádiz, Spain
Hospital Galdakao-Usansolo Not yet recruiting
Galdacano, Spain
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain
Hospital Infanta Sofia Not yet recruiting
San Sebastián de los Reyes, Spain
Sponsors and Collaborators
European Association of Urology Research Foundation
GlaxoSmithKline
Investigators
Principal Investigator: Peter FA Mulders, PhD EAU Research Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: European Association of Urology Research Foundation
ClinicalTrials.gov Identifier: NCT01435356     History of Changes
Other Study ID Numbers: EAU RF 2010-01, NTR2846, 2010-024355-85
Study First Received: September 2, 2011
Last Updated: September 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

Keywords provided by European Association of Urology Research Foundation:
Urinary Bladder neoplasms
Lymphoproliferative Disorders
Immune System Diseases
Cystectomy
Adjuvants, Immunologic
Immunologic Factors

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014