Back to resultsBCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
MAGE-A3 ASCI
BCG
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Non muscle invasive bladder cancer
Eligibility 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.
Sites / Locations
- Centre Hospitalier Universitaire Vaudois (CHUV)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NMIBC at intermediate risk of progression
NMIBC at high risk of progression
NMIBC at low risk of progression
Arm Description
Outcomes
Primary Outcome Measures
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Secondary Outcome Measures
Flow cytometric analysis of type and number of immune cell types in urine
Measurement of titers of antibodies against recMAGE-A3 in serum
Assessment of disease recurrence by control cystoscopy
Full Information
NCT ID
NCT01498172
First Posted
December 6, 2011
Last Updated
February 3, 2015
Sponsor
Patrice Jichlinski
Collaborators
Ludwig Center for Cancer Research of Lausanne, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01498172
Brief Title
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
Official Title
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrice Jichlinski
Collaborators
Ludwig Center for Cancer Research of Lausanne, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Non muscle invasive bladder cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NMIBC at intermediate risk of progression
Arm Type
Experimental
Arm Title
NMIBC at high risk of progression
Arm Type
Experimental
Arm Title
NMIBC at low risk of progression
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MAGE-A3 ASCI
Intervention Description
5 doses every 3 weeks
Intervention Type
Biological
Intervention Name(s)
BCG
Other Intervention Name(s)
Oncotice
Intervention Description
1 intravesical dose /week for 6 weeks
Primary Outcome Measure Information:
Title
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Flow cytometric analysis of type and number of immune cell types in urine
Time Frame
6 months
Title
Measurement of titers of antibodies against recMAGE-A3 in serum
Time Frame
6 months
Title
Assessment of disease recurrence by control cystoscopy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Jichlinski, MD
Organizational Affiliation
University Hospital Lausanne (CHUV)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
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