A Phase 1/2 interventional study of BCG Solution and Best Practice in Non-Muscle Invasive Bladder Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 1/2, Interventional, and Health services research
This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma. Bacillus Calmette Guerin (BCG) is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. For patients with bladder cancer it is used in a solution and placed directly into the bladder to stimulate the immune system to attack the cancer cells. Bladder cancer patients often face frequent clinic visits for BCG treatment, creating time, cost, and require help from caregivers or family members. BCG treatment may be able to be given at home which would improve access and quality of care without compromising treatment effectiveness for patients with non-muscle invasive bladder carcinoma.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of home-based delivery of intravesical BCG therapy as measured by successful administration of BCG therapy in at least four of five in-home induction doses.
II. To evaluate the correct administration of intravesical BCG.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients achieving an adequate therapy regimen, defined as at least five of six induction instillations (including the first in-clinic dose) plus at least two of three maintenance instillations.
II. To evaluate the safety of home-based intravesical BCG, measured by the incidence, type, and severity of treatment-emergent adverse events (TEAEs) graded per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0, including predefined events of interest (symptomatic urinary tract infection [UTI], fever > 38.5 °C, urosepsis, local/distant BCG-related granulomatous reactions, reactive arthritis, and moderate- severe lower urinary tract symptoms (LUTS): dysuria, frequency, urgency, hematuria).
III. Compare the cost of home-based therapy to in-office therapy. IV. Assess patient reported outcomes related to IVa. Quality of life; IVb. Satisfaction with care; IVc. Treatment-related burden. V. Measure treatment response defined as the absence of visible tumor during cystoscopy combined with negative urine cytology at 3- and 6-month surveillance points.
OUTLINE:
Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns.
After completion of study treatment, patients are followed up at 3 and 6 months.
272 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 116 are open to participants now.
This study's planned enrollment of 49 is below the median of 69 across 210 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Clinically confirmed to be intermediate or high risk according to the American Urological Association (AUA)/Society of Urologic Oncology (SUO) risk stratification system:
Subject agreement that their home:
Exclusion Criteria:
Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns.
Biological: BCG Solution · Other: Best Practice · Procedure: Cystoscopy · Other: Home Health Encounter · Other: Survey Administration
Given via installation in the bladder
Also known as: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Receive BCG in a hospital-based clinical setting
Also known as: standard of care, standard therapy
Undergo cystoscopy
Also known as: CS
Receive BCG installation at home by trained home health nurses
Also known as: HH, Home, Home Care Visit, Home Health
Ancillary studies
Successful administration of Bacille Calmette Guerin (BCG) therapy in at least four of five in-home induction doses (feasibility)
Feasibility will be considered achieved if ≥ 85% complete ≥ 4 of 5 induction and ≥ 2 of 3 maintenance doses. Feasibility will be considered acceptable if the lower bound of the 95% confidence interval exceeds the pre-specified threshold of 70%. The estimated completion proportion will be reported with an exact 95% Clopper-Pearson confidence interval.
Time frame: Up to 6 months
Ability to reconstitute TICE BCG
Successful reconstitution of one vial of TICE BCG in 50 mL of sterile preservative-free saline
Time frame: Up to 6 months
Correct installation technique
Defined as administration of reconstituted TICE BCG through a urethral catheter into the bladder.
Time frame: Up to 6 months
Completion of post instillation instructions to attempt to retain the BCG solution
Completion of post instillation instructions to attempt to retain the BCG solution for approximately 2 hours, or until the patient develops a strong urge to urinate. This will be measured in minutes from instillation to voiding and recorded by the research team during a follow-up telephone call.
Time frame: From instillation to voiding, assessed up to 3 hours
Incidence of post BCG adverse events
Defined as evaluation of any symptoms or adverse effects occurring after BCG therapy.
Time frame: Up to 6 months
Proportion of patients achieving an adequate therapy regimen
Defined as at least five of six induction instillations (including the first in-clinic dose) plus at least two of three maintenance instillations.
Time frame: Up to 6 months
Incidence of treatment-emergent adverse events (AE)
Graded per Common Terminology Criteria for Adverse Events version 6.0, including predefined events of interest (symptomatic urinary tract infection, fever \> 38.5 °C, urosepsis, local/distant BCG-related granulomatous reactions, reactive arthritis, and moderate- severe lower urinary tract infection: dysuria, frequency, urgency, hematuria). Occupational exposure incidents among trained home health nurses will also be captured. Descriptive statistics will be used for laboratory abnormalities and physical findings. Kaplan-Meier analysis with log-rank tests may be applied descriptively to assess time to first grade ≥ 3 AE.
Time frame: Up to 6 months
Cost of home-based therapy versus in-office therapy
Patient-reported questionnaires will capture direct out-of-pocket expenses, travel and parking costs, time spent commuting, and caregiver involvement. Responses will be analyzed descriptively, and paired comparisons between the in-clinic and home-based settings (for the first induction dose) will be performed. Continuous outcomes (e.g., travel time, caregiver hours) will be compared using paired t-tests or Wilcoxon signed-rank tests, depending on the distribution. Categorical outcomes (e.g., missed work, caregiver assistance) will be compared using McNemar's test.
Time frame: Up to 6 months
Satisfaction with care
Responses will be summarized descriptively and compared between in-clinic and home-based treatment using Wilcoxon signed-rank tests. Exploratory ordinal logistic regression may be used to identify predictors of high satisfaction.
Time frame: Up to 6 months
Treatment-related burden
A treatment burden questionnaire will be administered weekly after each treatment. The questionnaire is Adapted from the Treatment Burden Questionnaire (TBQ) and the Functional Assessment of Cancer Therapy-Bladder (FACTBl).
Time frame: Up to 6 months
Treatment response
Defined as the absence of visible tumor during cystoscopy combined with negative urine cytology at 3- and 6-month surveillance points. Will be summarized as proportions with exact 95% Clopper-Pearson confidence intervals.
Time frame: Up to 6 months
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: BCG Solution
Non-Muscle Invasive Bladder Neoplasms →
Ohio State University Comprehensive Cancer Center →