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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01878188
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Anchiano Therapeutics Israel Ltd.

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

Condition or disease Intervention/treatment Phase
Transitional Cell Carcinoma of Bladder Drug: BC-819/PEI Drug: BCG Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
Study Start Date : February 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: 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 Name: 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 Name: OncoTICE




Primary Outcome Measures :
  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 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Recurrence of bladder cancer after treatment with BC-819/PEI and BCG [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878188


Locations
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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, Israel
Sponsors and Collaborators
Anchiano Therapeutics Israel Ltd.
Investigators
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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

Additional Information:
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Responsible Party: Anchiano Therapeutics Israel Ltd.
ClinicalTrials.gov Identifier: NCT01878188     History of Changes
Other Study ID Numbers: BC-BLAD-01
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

Keywords provided by Anchiano Therapeutics Israel Ltd.:
inodiftagene vixteplasmid

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic