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
NCT number | NCT01498172 |
Other study ID # | URO-68/11 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | December 6, 2011 |
Last updated | February 3, 2015 |
Start date | January 2012 |
Verified date | February 2015 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | |
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Patrice Jichlinski | GlaxoSmithKline, Ludwig Center for Cancer Research of Lausanne |
Switzerland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06034015 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04235764 -
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
|
||
Completed |
NCT02371447 -
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04081246 -
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
|
N/A | |
Recruiting |
NCT06059547 -
Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
|
Phase 2 | |
Terminated |
NCT04779489 -
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer
|
N/A | |
Not yet recruiting |
NCT04493489 -
Propranolol Adjuvant Treatment of Bladder Cancer
|
Phase 2 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT04537221 -
Nordic Cystectomy Study III - Transfusion
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05562791 -
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
|
Phase 1 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT02781428 -
To Detect the Sensitivity of the UroMark Assay
|
||
Recruiting |
NCT04738630 -
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03978624 -
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
|
Phase 2 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A |