BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Ludwig Center for Cancer Research of Lausanne
GlaxoSmithKline
Information provided by (Responsible Party):
Patrice Jichlinski, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01498172
First received: December 6, 2011
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.


Condition Intervention Phase
Bladder Cancer
Biological: MAGE-A3 ASCI
Biological: BCG
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Flow cytometric analysis of type and number of immune cell types in urine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measurement of titers of antibodies against recMAGE-A3 in serum [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assessment of disease recurrence by control cystoscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMIBC at intermediate risk of progression Biological: MAGE-A3 ASCI
5 doses every 3 weeks
Biological: BCG
1 intravesical dose /week for 6 weeks
Other Name: Oncotice
Experimental: NMIBC at high risk of progression Biological: MAGE-A3 ASCI
5 doses every 3 weeks
Biological: BCG
1 intravesical dose /week for 6 weeks
Other Name: Oncotice
Experimental: NMIBC at low risk of progression Biological: MAGE-A3 ASCI
5 doses every 3 weeks

  Eligibility

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

Inclusion Criteria:

  • Male or female patient with histological confirmation of NMIBC
  • Full recovery from surgery (TUR) from 1 to 6 weeks
  • Karnofsky performance status of 60% or more
  • Laboratory parameters for vital functions should be in the normal range
  • Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
  • Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment

Exclusion Criteria:

  • Muscle invasive bladder cancer
  • Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
  • Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
  • History of severe allergic reactions to vaccines or unknown allergens
  • Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.

The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted

  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
  • Lack of availability for immunological and clinical follow-up assessment
  • For female patients of childbearing potential: positive urine or serum pregnancy test or lactating
  • Known positive HIV test, HBV, HCV.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498172

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Patrice Jichlinski
Ludwig Center for Cancer Research of Lausanne
GlaxoSmithKline
Investigators
Principal Investigator: Patrice Jichlinski, MD University Hospital Lausanne (CHUV)
  More Information

No publications provided

Responsible Party: Patrice Jichlinski, Chief of Urology Department, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01498172     History of Changes
Other Study ID Numbers: URO-68/11
Study First Received: December 6, 2011
Last Updated: February 17, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Lausanne Hospitals:
Non muscle invasive bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014