Bladder Cancer Clinical Trial
Official title:
Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune
system and stop cancer cells from growing.
PURPOSE: This randomized phase III trial is studying four different regimens of BCG and
comparing how well they work in treating patients who have undergone surgery for bladder
cancer.
OBJECTIVES:
- Demonstrate that after complete transurethral resection of all papillary tumors, one
third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose
BCG and short term maintenance is equivalent to long term maintenance with respect to
duration of disease free interval, recurrence rate, percentage of patients with an
increase in T-category to greater than T1, and the incidence of carcinoma in situ
during follow-up.
- Demonstrate that one third dose BCG and short term maintenance are associated with
fewer local and systemic side effects.
OUTLINE: This is a prospective randomized study.
At 7-15 days after transurethral resection, patients will begin receiving one of the
following four regimens:
- Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term
maintenance. Patients receive a one third dose of BCG instilled once a week for 6
weeks, followed by three weekly instillations at months 3, 6, and 12.
- Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of
BCG instilled once a week for 6 weeks, followed by three weekly instillations at months
3, 6, and 12.
- Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third
dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations
at months 3, 6, 12, 18, 24, 30 and 36.
- Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of
BCG instilled once a week for 6 weeks, followed by three weekly instillations at months
3, 6, 12, 18, 24, 30, and 36.
The patient is followed every 3 months for the first 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: 1288 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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 |