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

NCT ID: NCT01878188

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-10-31

Brief 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

Conditions

Transitional Cell Carcinoma of Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BC-819/PEI and BCG alternating

4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG

Group Type: EXPERIMENTAL

BC-819/PEI

Intervention Type: DRUG

Intravesical instillation

BCG Vaccine

Intervention Type: DRUG

intravesical instillations

BC-819/PEI and BCG Vaccine sequential

4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG

Group Type: EXPERIMENTAL

BC-819/PEI

Intervention Type: DRUG

Intravesical instillation

BCG Vaccine

Intervention Type: DRUG

intravesical instillations

twice-weekly treatments of BC-819 and BCG

6 twice-weekly treatments of BC-819/PEI and BCG

Group Type: EXPERIMENTAL

BC-819/PEI

Intervention Type: DRUG

Intravesical instillation

BCG Vaccine

Intervention Type: DRUG

intravesical instillations

Interventions

BC-819/PEI

Intravesical instillation

Intervention Type: DRUG

BCG Vaccine

intravesical instillations

Intervention Type: DRUG

Other Intervention Names

OncoTICE

Eligibility Criteria

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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anchiano Therapeutics Israel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ami Sidi, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Sarel Halachmi, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai-Zion Medical Center, Haifa, Israel

Ilan Leibovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar-Saba, Israel

Ofer Gofrit, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Karem Medical Center

Amnon Zisman, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe Medical Center

Abraham Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Hospital,Haifa

Haim Matzkin, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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

Ẕerifin, , Israel

Countries

Israel

Related Links

http://www.biocancell.com/

Related Info

Other Identifiers

BC-BLAD-01

Identifier Type: -

Identifier Source: org_study_id