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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014