Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Transitional Cell Carcinoma of Bladder Clinical Trial

Official title:

Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878188
• Other study ID #: BC-BLAD-01
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: October 2017

Study information

• Verified date: March 2019
• Source: Anchiano Therapeutics Israel Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)

• Recurrence after treatment with BC-819/PEI and BCG

• Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder

• After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with superficial papillary transitional cell carcinoma of the bladder for whom BCG is clinically indicated. If CIS is present, diagnosis needs to be confirmed by biopsy prior to the start of the study.

2. Males or females more than 18 years old

3. All papillary tumors must be resected within 8 weeks prior to the start of study therapy.

4. ECOG performance status 2 or less.

5. Adequate hematologic function, as demonstrated by

1. Hemoglobin 10 g/dL or higher

2. ANC 1.5 x 109/L or higher

3. Platelets higher than 100 x 109/L

6. Adequate liver and renal function as demonstrated by

1. AST and ALT each 3.0 x ULN or less

2. Total bilirubin 1.5 x ULN or less

3. Creatinine 1.5 X ULN OR less, creatinine clearance >60 mL/min

7. If fertile and sexually active, must use adequate contraception

8. Must be able to comply with protocol requirements, including attendance at required clinic visits.

9. Patients must provide written informed consent.

Exclusion Criteria:

1. Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery.

2. Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.

3. Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment.

4. Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment.

5. Patients who have received radiation therapy for bladder cancer at any time or for any condition within 4 months prior to the start of protocol treatment.

6. Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy.

7. Patients who are receiving coumadin.

8. Patients who have had to discontinue a past course of BCG due to toxicity.

9. Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations.

10. Patients who are known to be HIV positive.

11. Females who are pregnant or breast feeding.

12. Presence of any medical, psychological or social condition or situation which may, in the investigator's opinion, make it difficult for the patient to tolerate study medication or comply with study procedures and other requirements. This includes but is not limited to active infections, poorly controlled diabetes, uncontrolled cardiac arrhythmias, angina pectoris, or hypertension.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of Bladder
• Urinary Bladder Neoplasms

Intervention

Drug:
• BC-819/PEI
Intravesical instillation
• BCG Vaccine
intravesical instillations

Locations

Country	Name	City	State
Israel	Bnai Zion MC	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Hadassah Ein Karem Medical Center	Jerusalem
Israel	Meir MC	Kfar Saba
Israel	Tel Aviv Medical Center	Tel Aviv
Israel	Assaf Harofe Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Anchiano Therapeutics Israel Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG by number of subjects with AEs and change from baseline for clinical safety laboratory tests		3 months
Secondary	Recurrence of bladder cancer after treatment with BC-819/PEI and BCG		3 months

External Links

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