Clinical trial · Interventional
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
NCT02365207CI-TRIAL-00041474terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual of subjects and lack of funding
Summary
Brief summary (as posted)
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
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 |
|---|---|---|---|
| BCG strain of Mycobacterium bovis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCG treatment of invasive bladder cancer
- description
- Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
- interventionNames
- Drug: BCG strain of Mycobacterium bovis
Primary outcomes (1)
- measure
- Ability of BCG to Enhance Tumor Specific Immunity
- timeFrame
- At cystectomy at 3-6 weeks after BCG treatment
- description
- The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have suspected or known invasive (≥T1) bladder cancer 2. Be able to give informed consent 3. Be age 18 or older 4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month) Exclusion Criteria: 1. Have non-invasive (\<T1) bladder cancer 2. Unable to give informed consent 3. \< 18 or older 4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)
References
Publications (0)
Data not yet available
No reference posted for this study.