Codex: A Study of Experimental Inodiftagene Vixteplasmid (BC-819) in Unresponsive Non-Muscle Invasive Bladder Cancer

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Non-Muscle Invasive Bladder Cancer, bladder cancer
Type: Drug study, Phase 2
Target:
6 Participants
Investigator:
Description
This study is for patients who have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin). The cancer has returned after treatment(s).

This research study will test an experimental medicine named BC-819. The study team hopes to learn if BC-819 can prevent or delay tumor recurrence. It will be tested in patients with non-muscle invasive bladder cancer that has become unresponsive to BCG treatment.

BC-819 is made from DNA, a type of genetic material. DNA is a short name for deoxyribonucleic acid. BC-819 is a liquid solution that contains many small pieces of DNA which are called DNA plasmids. The DNA plasmid works by causing a change inside cancer cells that have a gene called H19. The plasmid does not function in your normal cells, because these cells do not have the H19 gene. The way the plasmids enter the cells in your body is considered gene transfer. Once inside a malignant cell, the plasmid is toxic and causes the cancer cell to die.

The study agent solution also contains a chemical called PEI (polyethyleneimine). PEI helps the plasmid to enter the cancer cells. The BC-819/PEI liquid solution is given through a tube called a Foley catheter. This allows the liquid solution to flow directly into the bladder. This is the same way BCG was given.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Male or female patients ≥18 years of age at the time of consent
  2. Patient must have been adequately treated with BCG defined as at least one of the following (FDA 2018):
  3. At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
  4. At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
  5. A single course of induction BCG can qualify if the patient has T1 high-grade disease at first evaluation (see 3c)
  6. Patient must be BCG-unresponsive defined as at least one of the following (FDA 2018):
  7. Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was done 12 months after completion of adequate BCG therapy.
  8. Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. An assessment within 9 months can also qualify when no assessment was done 6 months after completion of adequate BCG therapy.
  9. T1 high-grade disease at the first evaluation following a single course of induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)
  10. Patient must have, at study entry, NMIBC indicated by 1 or more of the following:
  11. Ta or T1 high-grade disease
  12. CIS disease
  13. Patient must have no known evidence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra within 6 months of enrollment
  14. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  15. Patient must have adequate hematologic function, as demonstrated by the following:
  16. Hemoglobin level ≥10 g/dL
  17. Absolute neutrophil count ≥1.5 x 109/L
  18. Platelet count ≥100 x 109/L
  19. Patient must have adequate liver and renal function as demonstrated by the following:
  20. Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit of normal
  21. Total bilirubin ≤1.5 x upper limit of normal, unless prior documentation of Gilbert's syndrome in which case, 3.0 mg/dL is allowed
  22. Serum creatinine ≤1.5 x upper limit of normal or measured or calculated creatinine clearance ≥30 mL/min
  23. Female patients of childbearing potential must use maximally effective birth control during the period of therapy and for 1 month after the last study drug infusion
  24. Male patients who are sexually active must be willing to use a double barrier contraceptive method upon study enrollment, during the course of the study, and for 1 month after the last study drug infusion

Exclusion criteria:

  1. Patient has current or previous evidence of muscle invasive (muscularis propria) or metastatic bladder cancer disease
  2. Patient has received prior investigational therapy for NMIBC
  3. Patient has received any therapy for NMIBC within 10 weeks before the start of study treatment other than surgical resection, 1 dose of chemotherapy, and previous BCG
  4. Patient is intolerant to previous BCG treatment in the absence of meeting other criteria for BCG unresponsiveness and adequate BCG therapy
  5. Patient has received external beam radiation therapy for bladder cancer at any time or for any other condition
  6. Patient has an active infection, including urinary tract infection (viral, bacterial, or fungal) and cystitis
  7. Patient has urinary tract signs or symptoms that preclude retention of drug in the bladder; this does not include anticholinergic drugs
  8. Patient is known to have tested positive for human immunodeficiency virus (HIV). No HIV testing is required if patient is not known have tested positive
  9. Patient is female and is pregnant or breastfeeding
  10. Patient has a known presence or history of malignancy of other organ system within the 5 years before study start, with the exception of non-melanoma skin cancer; very low or low-risk prostate cancer; or patients who have been disease free for at least 2 years following stage 1 or 2 cancer
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You may be participating in the study for up to 102 weeks (approximately 2 years).
Recruitment period
From Dec. 4, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Non-muscle Invasive Bladder Cancer (NMIBC)