Transitional Cell Carcinoma of BladderPhase 1NCT01878188

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

A Phase 1 study testing BC-819/PEI and BCG Vaccine in people with Transitional Cell Carcinoma of Bladder, run by Anchiano Therapeutics Israel Ltd. at 7 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Transitional Cell Carcinoma of Bladder
What is being tested?: BC-819/PEI and BCG Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 7 sitesIsrael
Study dates: Feb 2013to Oct 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.
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Who cannot join

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.

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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.
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Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Israel7 sites

Bnai Zion MC
Haifa
Carmel Medical Center
Haifa
Wolfson Medical Center
Holon
Hadassah Ein Karem Medical Center
Jerusalem
Meir MC
Kfar Saba
Tel Aviv Medical Center
Tel Aviv
Assaf Harofe Medical Center
Tsrifin

Other trials in Israel

About this study

Official title: 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

Conditions: Transitional Cell Carcinoma of Bladder
Being tested: BC-819/PEI, BCG Vaccine
Keywords: inodiftagene vixteplasmid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BC-819/PEIDrug
Intravesical instillation
BCG VaccineDrug
Also called OncoTICE
intravesical instillations

Study groups in NCT01878188
Study group	Role	What they receive
BC-819/PEI and BCG alternating	Experimental	4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG Receives: 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 Receives: 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 Receives: Drug: BC-819/PEI; Drug: BCG Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 3 months

Secondary outcomes (1)

Recurrence of bladder cancer after treatment with BC-819/PEI and BCG
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Oct 2017

First posted14 Jun 2013 (estimated)
Study startFeb 2013
Primary completionOct 2015
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Transitional Cell Carcinoma of BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878188
Sponsor's protocol ID: BC-BLAD-01
Status last verified: Mar 2019
First submitted: 29 May 2013
Last updated: 11 Mar 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis

All Transitional Cell Carcinoma of Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma
ClinicalTrials.gov ID: NCT01878188
Acronym / sponsor ID: BC-BLAD-01
Conditions: Transitional Cell Carcinoma of Bladder
Keywords: inodiftagene vixteplasmid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Anchiano Therapeutics Israel Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2017 (actual)
First posted: 14 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BC-819/PEI and BCG alternating	Experimental	Drug: BC-819/PEI, Drug: BCG Vaccine4 or 6 weekly treatments of BC-819/PEI alternating with 6 treatments of BCG
BC-819/PEI and BCG Vaccine sequential	Experimental	Drug: BC-819/PEI, Drug: BCG Vaccine4 weekly treatments of BC-819/PEI followed by 6 weekly treatments of BCG
twice-weekly treatments of BC-819 and BCG	Experimental	Drug: BC-819/PEI, Drug: BCG Vaccine6 twice-weekly treatments of BC-819/PEI and BCG

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BC-819/PEIIntravesical instillation	Drug	BC-819/PEI and BCG Vaccine sequential, BC-819/PEI and BCG alternating, twice-weekly treatments of BC-819 and BCG
BCG VaccineAlso: OncoTICEintravesical instillations	Drug	BC-819/PEI and BCG Vaccine sequential, BC-819/PEI and BCG alternating, twice-weekly treatments of BC-819 and BCG

Primary outcome

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

1 secondary outcome

Recurrence of bladder cancer after treatment with BC-819/PEI and BCG
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Related InfoLink provided by the sponsor.

Related trials for Transitional Cell Carcinoma of Bladder

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ami Sidi, MD principal investigator

Wolfson Medical Center

Sarel Halachmi, MD principal investigator

Bnai-Zion Medical Center, Haifa, Israel

Ilan Leibovitch, MD principal investigator

Meir Medical Center, Kfar-Saba, Israel

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BC-819/PEI and BCG Vaccine in people with Transitional Cell Carcinoma of Bladder, run by Anchiano Therapeutics Israel Ltd. at 7 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01878188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.