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

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

• 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

Study Overview

• Status: Completed
• Conditions: Transitional Cell Carcinoma of Bladder
• Intervention / Treatment: Drug: BC-819/PEI; Drug: BCG Vaccine

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center
  • Haifa, Israel
    • Bnai Zion Mc
  • Holon, Israel
    • Wolfson Medical Center
  • Jerusalem, Israel
    • Hadassah Ein Karem Medical Center
  • Kfar Saba, Israel
    • Meir MC
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
  • Zerifin, Israel
    • Assaf Harofe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BC-819/PEI and BCG alternating; 4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG	Drug: BC-819/PEI; Intravesical instillation; Drug: BCG Vaccine; intravesical instillations; Other Names: OncoTICE
Experimental: BC-819/PEI and BCG Vaccine sequential; 4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG	Drug: BC-819/PEI; Intravesical instillation; Drug: BCG Vaccine; intravesical instillations; Other Names: OncoTICE
Experimental: twice-weekly treatments of BC-819 and BCG; 6 twice-weekly treatments of BC-819/PEI and BCG	Drug: BC-819/PEI; Intravesical instillation; Drug: BCG Vaccine; intravesical instillations; Other Names: OncoTICE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Recurrence of bladder cancer after treatment with BC-819/PEI and BCG	3 months

Collaborators and Investigators

• Sponsor: Anchiano Therapeutics Israel Ltd.
• Investigators: Principal Investigator: Ami Sidi, MD, Wolfson Medical Center; Principal Investigator: Sarel Halachmi, MD, Bnai-Zion Medical Center, Haifa, Israel; Principal Investigator: Ilan Leibovitch, MD, Meir Medical Center, Kfar-Saba, Israel; Principal Investigator: Ofer Gofrit, MD, Hadassah Ein Karem Medical Center; Principal Investigator: Amnon Zisman, MD, Assaf Harofe Medical Center; Principal Investigator: Abraham Stein, MD, Carmel Hospital,Haifa; Principal Investigator: Haim Matzkin, MD, Tel Aviv Medical Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: inodiftagene vixteplasmid
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; BCG Vaccine
• Other Study ID Numbers: BC-BLAD-01