BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
NCT ID: NCT01498172
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NMIBC at intermediate risk of progression
MAGE-A3 ASCI
5 doses every 3 weeks
BCG
1 intravesical dose /week for 6 weeks
NMIBC at high risk of progression
MAGE-A3 ASCI
5 doses every 3 weeks
BCG
1 intravesical dose /week for 6 weeks
NMIBC at low risk of progression
MAGE-A3 ASCI
5 doses every 3 weeks
Interventions
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MAGE-A3 ASCI
5 doses every 3 weeks
BCG
1 intravesical dose /week for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ludwig Center for Cancer Research of Lausanne
OTHER
GlaxoSmithKline
INDUSTRY
Patrice Jichlinski
OTHER
Responsible Party
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Patrice Jichlinski
Chief of Urology Department
Principal Investigators
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Patrice Jichlinski, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Lausanne (CHUV)
Locations
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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
Countries
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Other Identifiers
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URO-68/11
Identifier Type: -
Identifier Source: org_study_id
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