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

NCT01878188 | Completed Phase 1

• 1 other identifier: BC-BLAD-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

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

Keywords

inodiftagene vixteplasmid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 months

Study Arms (3)

BC-819/PEI and BCG alternating

EXPERIMENTAL

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

Drug: BC-819/PEI; Drug: BCG Vaccine

BC-819/PEI and BCG Vaccine sequential

EXPERIMENTAL

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

Drug: BC-819/PEI; Drug: BCG Vaccine

twice-weekly treatments of BC-819 and BCG

EXPERIMENTAL

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

Drug: BC-819/PEI; Drug: BCG Vaccine

Interventions

BC-819/PEI DRUG

Intravesical instillation

BC-819/PEI and BCG Vaccine sequential; BC-819/PEI and BCG alternating; twice-weekly treatments of BC-819 and BCG

BCG Vaccine DRUG

intravesical instillations

Also known as: OncoTICE

BC-819/PEI and BCG Vaccine sequential; BC-819/PEI and BCG alternating; twice-weekly treatments of BC-819 and BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females more than 18 years old
• All papillary tumors must be resected within 8 weeks prior to the start of study therapy.
• ECOG performance status 2 or less.
• Adequate hematologic function, as demonstrated by
• Hemoglobin 10 g/dL or higher
• ANC 1.5 x 109/L or higher
• Platelets higher than 100 x 109/L
• Adequate liver and renal function as demonstrated by
• AST and ALT each 3.0 x ULN or less
• Total bilirubin 1.5 x ULN or less
• Creatinine 1.5 X ULN OR less, creatinine clearance \>60 mL/min
• If fertile and sexually active, must use adequate contraception
• Must be able to comply with protocol requirements, including attendance at required clinic visits.
• Patients must provide written informed consent.

You may not qualify if:

• Patients who are candidates for either partial or total bladder resection, unless either medically contraindicated or who have refused surgery.
• Patients with a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.
• Patients who have received cytotoxic drugs, systemic corticosteroids or any investigational drug for any indication within 4 weeks of the start of protocol treatment.
• Patients who have received any intravesical therapy other than surgical resection within 8 weeks prior to the start of protocol treatment.
• 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.
• Patients who have active infections, including urinary tract infections, whether viral, bacterial or fungal and requiring therapy.
• Patients who are receiving coumadin.
• Patients who have had to discontinue a past course of BCG due to toxicity.
• Patients who are having urinary tract signs or symptoms from recent urinary tract procedures or manipulations, such as biopsies or catheterizations.
• Patients who are known to be HIV positive.
• Females who are pregnant or breast feeding.
• 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.

Sponsors & Collaborators

• Anchiano Therapeutics Israel Ltd.: lead

Study Sites (7)

Bnai Zion MC

Haifa, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Hadassah Ein Karem Medical Center

Jerusalem, Israel

Location

Meir MC

Kfar Saba, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Assaf Harofe Medical Center

Ẕerifin, Israel

Location

Related Links

• Related Info

MeSH Terms

Interventions

BCG Vaccine

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 14, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

IL (7)