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Brief Title: Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: 19-374
  • Secondary ID: N/A
  • NTC ID: NCT04179162
  • Sponsor: Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    November 22, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: evaluate the MTD (Phase I)

Primary Outcome 1 - Timeframe: 1 year

Primary Outcome 2 - Measure: proportion of patients who are disease free

Primary Outcome 2 - Timeframe: 6 months after the start of treatment

CONDITION

  • Non-Muscle Invasive Bladder Cancer (NMIBC)

ELIGIBILITY

Inclusion Criteria:
Recurrent high-grade NMIBC (Tis, TaHG, or T1) within 24 months of the last treatment with BCG (with or without IFN)

- Pathologic confirmation of stage, grade, and urothelial histology by the Department of Pathology at MSK

- All visible papillary lesions macroscopically resected within 60 days of treatment initiation

- Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment

- Receipt of restaging transurethral resection (TUR) for any tumor with invasion into the lamina propria (HGT1) as part of standard care

- Age ≥18 years

- Karnofsky performance status ≥60%

- Informed consent
Exclusion Criteria:
Positive pregnancy test
Known contraindications to BCG
History of systemic hypersensitivity reaction or history of febrile systemic BCG reaction

- Febrile illness or persistent gross hematuria

- Active tuberculosis

- Immunosuppression due to congenital or acquired immune deficiency, concurrent immune suppressive disease, systemic cancer therapy, or chronic immunosuppressive therapy other than topical or inhaled corticosteroids

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

- Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma
BCG-unresponsive NMIBC as defined by the FDA:
HGT1 within 3 months after an induction BCG course (received ≥5 of 6 doses)

- Persistent or recurrent high-grade NMIBC (Tis, Ta, T1) within 6 months of ≥5 of 6 doses of induction BCG therapy and ≥2 of 3 doses of maintenance BCG therapy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Eugene Pietzak, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Eugene Pietzak, MD

Phone: 646-422-4781, 1-646-422-4394

Email: pietzake@mskcc.org, dalbagng@mskcc.org

LOCATION

Facility Status Contact
Facility: Hartford Healthcare (Data Collection)
Hartford, Connecticut 06102
United States
Status: Recruiting Contact: Contact
Anoop Meraney, MD
860-947-8500
augustia@mskcc.org
Facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Contact
Eugene Pietzak, MD
646-422-4781
Facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Eugene Pietzak, MD
646-422-4781
Facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: Contact
Eugene Pietzak, MD
646-422-4781
Facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Eugene Pietzak,, PhD
646-422-4781
Facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Eugene Pietzak, MD
646-422-4781
Facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Eugene Pietzak, MD
646-422-4781
Facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States
Status: Recruiting Contact: Contact
Anisha Augustin
646-422-4781