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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498172
• Other study ID #: URO-68/11
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2011
• Last updated: February 3, 2015
• Start date: January 2012

Study information

• Verified date: February 2015
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• MAGE-A3 ASCI
5 doses every 3 weeks
• BCG
1 intravesical dose /week for 6 weeks

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Patrice Jichlinski	GlaxoSmithKline, Ludwig Center for Cancer Research of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability		6 months
Secondary	Flow cytometric analysis of type and number of immune cell types in urine		6 months
Secondary	Measurement of titers of antibodies against recMAGE-A3 in serum		6 months
Secondary	Assessment of disease recurrence by control cystoscopy		6 months