BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients

February 3, 2015 updated by: Patrice Jichlinski

BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Oncotice
Experimental: NMIBC at low risk of progression
Biological: MAGE-A3 ASCI
5 doses every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Flow cytometric analysis of type and number of immune cell types in urine
Time Frame: 6 months
6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
Time Frame: 6 months
6 months
Assessment of disease recurrence by control cystoscopy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patrice Jichlinski

Collaborators

GlaxoSmithKline
Ludwig Center for Cancer Research of Lausanne

Investigators

  • Principal Investigator: Patrice Jichlinski, MD, University Hospital Lausanne (CHUV)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-68/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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