Status:
COMPLETED
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
Lead Sponsor:
Patrice Jichlinski
Collaborating Sponsors:
Ludwig Center for Cancer Research of Lausanne
GlaxoSmithKline
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01498172
Start Date
January 1 2012
Last Update
February 4 2015
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011