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Cancer Vaccine

BCG + Gemcitabine for Relapsed Bladder Cancer

Phase 1 & 2

Recruiting

Led By Eugene Pietzak, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status ≥60%

Age ≥18 years

Must not have

Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma

History of or currently being treated for muscle-invasive (i.e., stage T2 or higher) or metastatic urothelial cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if BCG and gemcitabine are safe and effective when used together to treat BCG-relapsing bladder cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include irritation at the injection site from BCG and typical chemotherapy-related issues from Gemcitabine such as nausea, low blood counts leading to infection risk or bleeding problems, fatigue, fever due to immune response activation by BCG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional help.

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I am 18 years old or older.

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My bladder cancer has returned within 2 years after BCG treatment.

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My cancer's type and stage have been confirmed by MSK's Pathology Department.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have or am being treated for advanced bladder cancer.

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I am immunosuppressed due to a condition or treatment, not including topical or inhaled steroids.

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My bladder cancer came back after completing most of my BCG therapy.

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I do not have a fever or ongoing visible blood in my urine.

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I have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

evaluate the MTD (Phase I)

Disease

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bacillus Calmette-Guérin (BCG) and GemcitabineExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bacillus Calmette-Guérin (BCG)

2014

Completed Phase 2

~1980

Gemcitabine

2017

Completed Phase 3

~1920