Clinical trial NCT01498172: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: Non muscle invasive bladder cancer
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Ludwig Center for Cancer Research of Lausanne
name: GlaxoSmithKline
First posted: 2011-12-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Flow cytometric analysis of type and number of immune cell types in urine
timeFrame: 6 months
measure: Measurement of titers of antibodies against recMAGE-A3 in serum
timeFrame: 6 months
measure: Assessment of disease recurrence by control cystoscopy
timeFrame: 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
Study officials:
affiliation: University Hospital Lausanne (CHUV)
name: Patrice Jichlinski, MD
role: PRINCIPAL_INVESTIGATOR
References: