BCG + Gemcitabine for Relapsed Bladder Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Eugene Pietzak, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Active tuberculosis, Immunosuppression, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug BCG + Gemcitabine for relapsed bladder cancer?

Research shows that while BCG is effective in reducing tumor recurrences, some patients do not respond to it. Studies suggest that gemcitabine can be a safe and effective alternative for those who do not respond to BCG, offering another option for managing bladder cancer.

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Is the combination of BCG and Gemcitabine safe for humans?

Research shows that both BCG and Gemcitabine have been studied for their safety in treating bladder cancer. While results vary, studies generally indicate that these treatments are considered safe, with side effects being reported and compared in different studies.

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How is the BCG + Gemcitabine drug for relapsed bladder cancer different from other treatments?

The BCG + Gemcitabine drug is unique because it combines an immunotherapy (BCG) with a chemotherapy drug (Gemcitabine) to treat bladder cancer that has returned after initial BCG treatment failed. This combination aims to enhance the effectiveness of treatment by using two different mechanisms to target cancer cells.

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Eligibility Criteria

This trial is for adults with high-grade non-muscle invasive bladder cancer that has returned after BCG treatment. Participants must have had all visible tumors removed recently, no upper urinary tract cancer in the last year, and a good performance status. Pregnant individuals, those with BCG contraindications or severe reactions to it, active tuberculosis, immune deficiencies, muscle-invasive or metastatic urothelial carcinoma are excluded.

Inclusion Criteria

I can care for myself but may need occasional help.

Informed consent

I am 18 years old or older.

Exclusion Criteria

My cancer has spread to areas like the urethra, ureter, or renal pelvis.

I have or am being treated for advanced bladder cancer.

My bladder cancer did not respond to BCG treatment after receiving most of the doses.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combination intravesical chemoimmunotherapy with BCG and gemcitabine. Gemcitabine is administered twice-weekly at weeks 1, 4, 7, and 10, and BCG is administered once-weekly at weeks 2, 3, 5, 6, 8, and 9.

10 weeks

8 visits for gemcitabine, 6 visits for BCG (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including urine cytology and cystoscopy.

6 months

Regular follow-up visits (in-person)

Long-term follow-up

Participants are monitored for long-term safety and effectiveness, with a focus on disease-free status.

1 year

Participant Groups

The study tests the safety and effectiveness of combining Bacillus Calmette-Guérin (BCG) with increasing doses of Gemcitabine in treating bladder cancer that's come back after BCG therapy. The goal is to find the highest dose of Gemcitabine that works well with BCG and causes few or mild side effects.

Group I: Bacillus Calmette-Guérin (BCG) and Gemcitabine Experimental Treatment 2 Interventions

Eligible patients will receive combination intravesical chemoimmunotherapy. Treatment is sequential, with twice-weekly intravesical gemcitabine given at weeks 1, 4, 7, and 10, for a total of 8 doses, administered in a standard fashion. In phase I, the dose of gemcitabine will depend on the dose level being assessed for the determination of the MTD. phase II, 1 dose level will be given (the MTD from phase I). Fixed doses of once-weekly intravesical BCG therapy (TICE strain, 50 mg) will be given at weeks 2 (+/- 2 days), 3 (+/- 2 days), 5 (+/- 2 days), 6 (+/- 2 days), 8 (+/- 2 days), and 9 (+/- 2 days), for a total of 6 doses, also administered in a standard fashion. All intravesical therapy will be administered in the chemotherapy suite on an outpatient basis, in accordance with standard clinical practice. Intravesical therapies will be retained in the bladder for up to 2 h (BCG) or 1 h (gemcitabine), or as tolerated.

Bacillus Calmette-Guérin (BCG) is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as TheraCys for:

• Non-muscle invasive bladder cancer
• Upper tract urothelial carcinoma

🇨🇦 Approved in Canada as Immun BCG for:

• Non-muscle invasive bladder cancer

🇪🇺 Approved in European Union as TICE BCG for:

• Non-muscle invasive bladder cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale, NY

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge, NJ

Hartford Healthcare (Data Collection) Hartford, CT

Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Intravesicle gemcitabine in management of BCG refractory superficial TCC of urinary bladder-our experience. [2022] The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (according to the WHO). Though intravesical adjuvant therapy with bacillus Calmette-Guérin (BCG) is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon develop BCG failure. Hence, there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim is to study the efficacy, tolerability, and safety of intravesical gemcitabine in managing BCG refractory superficial bladder malignancy.

2. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer: a multicenter prospective randomized trial. [2022] The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC).

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intravesical gemcitabine in BCG-refractory T1G3 transitional cell carcinoma of the bladder: a pilot study. [2022] The aim of this pilot study is to analyze the safety and short-term efficacy of gemcitabine (GEM) as salvage intravesical therapy in a very selected population of bacille Calmette-Guérin (BCG)-resistant T1G3 patients.

4. India pubmed.ncbi.nlm.nih.gov

Management of BCG non-responders with fixed dose intravesical gemcitabine in superficial transitional cell carcinoma of urinary bladder. [2021] The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (WHO). Though intravesical adjuvant therapy with BCG is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon become BCG failure. Hence there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim was to study the efficacy, tolerability and safety of intravesical Gemcitabine in managing BCG-refractory superficial bladder malignancy.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Bacillus Calmette-Guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. [2022] To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer.

6. New Zealand pubmed.ncbi.nlm.nih.gov

The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis. [2022] Several studies have compared the safety and efficacy of intravesical gemcitabine (Gem) with Bacille Calmette-Guérin (BCG) for non-muscle invasive bladder cancer. However, the results are not consistent. We carried out a meta-analysis to provide a more comprehensive analysis of the efficacy and safety of these 2 drugs.

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer. [2022] To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration.

8. United States pubmed.ncbi.nlm.nih.gov

Intravesical gemcitabine for high risk, nonmuscle invasive bladder cancer after bacillus Calmette-Guérin treatment failure. [2022] We report our experience with intravesical gemcitabine for bladder cancer after failed bacillus Calmette-Guérin treatment.