Clinical trial · Interventional
PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
A Study Evaluating the Safety and Tolerability of Percutaneous Vaccination Prior to Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Mycobacteria for Non-Muscle Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette-Guerin (BCG) | Drug | Bacillus Calmette-Guerin BCG | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- non-muscle invasive bladder cancer
- description
- Every patient meeting eligibility criteria will receive a standard WHO adult potency Bacillus Calmette-Guerin (BCG) immunization (1cc/50mg live mycobacilli) in the right or left deltoid. Following a 19 - 31day wait period after BCG vaccination patients will then receive standard strength BCG intravesical therapy returning once a week for 6 consecutive weeks. Cystoscopy will be performed at 3 and 6 months. Interventions: BCG immunization in deltoid and BCG intravesical therapy once a week for 6 weeks.
- interventionNames
- Drug: Bacillus Calmette-Guerin (BCG)
Primary outcomes (1)
- measure
- BCG response
- timeFrame
- 3 months after baseline
- description
- Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: The patient must: * Be 18 years of age or older * Be able to give informed consent * Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer * Determined by treating urologist to be a good candidate for BCG Induction Therapy * Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent Exclusion Criteria: The patient cannot: * Be less than18 years of age * Unable to give informed consent * Have a history of muscle invasive bladder cancer * Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids) * Have a history of tuberculosis and/or received BCG Percutaneous Vaccination * Pregnant or planning to become pregnant.
References
Publications (0)
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