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Non Muscle Invasive Bladder CancerNMIBC TURBT HGNCT01799499

A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)

A study testing TC-3 hydrogel in people with Non Muscle Invasive Bladder Cancer, run by UroGen Pharma Ltd. at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Non Muscle Invasive Bladder Cancer
What is being tested?
TC-3 hydrogel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
Mar 2013to Mar 2013
Phase
Interventional
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is 21 years of age or older.
  • Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
  • Single or multiple tumors (n≤7)
  • Naïve or Recurrent tumor
  • No prior history of HG and/or T1 and/or Tis
  • At least one Tumor ≥ 1mm as evaluated visually by the investigator
Show all 12Show fewer
  • Largest tumor diameter ≤ 30mm as evaluated visually by the investigator
  • Cystoscopic appearance of papillary Low grade tumor
  • The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers.
  • Good performance status (Karnofsky performance status 70% or greater).
  • No active urinary tract infection as confirmed by urine culture.
  • If the patient is a female of childbearing potential she is using an acceptable/effective method of contraception and has a negative pregnancy test at screening.

Who cannot join

  • Carcinoma In Situ (CIS).
  • Over 7 lesions
  • Lesion is larger than 30mm in diameter.
  • "High Grade" urine cytology.
  • Cystoscopic Appearance suspicious for HG and/or solid and/or Tis
  • histologic results of cold cup biopsy are indicative of HG tumor.
Show all 27Show fewer
  • Tumor located in prostatic urethra.
  • Previous systemic chemotherapy or pelvic radiotherapy.
  • Pregnant or breastfeeding patient.
  • Previous treatment with BCG within the last 24 months.
  • The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening.
  • Treatment with intravesical chemotherapy within the 3 last months.
  • The patient has/had any bladder tumor with histology other than TCC
  • Contraindication to MMC.
  • The patient has a history of urinary retention or a PVR≥250cc by bladder scan or ultrasound (PVR test may be repeated up to 3 times).
  • The patient has a bleeding disorder or a screening platelet count <50X109/L.
  • The patient has screening hemoglobin <10mg/dL.
  • The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive.
  • The patient has a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g. uncontrolled diabetes, compensated congestive heart failure (NYHA III and over), myocardial infarction within 6 months of study, unstable or uncontrolled hypertension or an active uncontrolled infection), which according to the PIs decision could compromise participation, compliance with scheduled visits and/or completion.
  • The patient participated in an investigational protocol within the past 90 days.
  • The patient has life expectancy of <3 years.
  • The patient had another malignancy or received therapy for any malignancy in the last five years except for:
  • Non-melanoma skin tumors
  • stage 0 (in situ) cervical carcinoma
  • prostatic carcinoma
  • The patient has documented vesica-ureteral reflux or an indwelling ureteral stent
  • The patient has the tumor in the bladder diverticulum

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Western Galilee Hospital Nahariya

    Nahariya

Other trials in Israel

About this study

This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy.

The investigators believe that this study is of importance on several aspects:

  1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
  2. If proved effective, this mode of treatment might save the need for TURBT performance and serve as a new mode of tumor ablation.
  3. Even if proved partially effective, this mode of treatment will diminish tumors size and/or number, thus enable a more limited TURBT procedure.
  4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT. This might improve the patient's prognostic outcome.
  5. If this experimental treatment will prove to have a better ablative effect in comparison to the standard of care known in the art, this could be translated to a better prophylactic effect of tumor recurrence.
  6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence prevention will enable us to reduce adverse effects of higher drug dosage.
Read the detailed description

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs such as Mitomycin C (MMC) or BCG. Unfortunately, this treatment approach is limited due to rapid dilution of the chemotherapeutic drug by the incoming urine and clearance by urination.

TheraCoat's core technology is based on a reverse thermal biodegradable gel (TC-3 Gel) (low viscosity at cold temperature (5°C) and gel appearance at body temperature)for drug retention in the urinary bladder.

Prior to instillation, the TC-3 Gel, in its liquid state, is mixed with MMC and instilled into the bladder by a standard catheter. Once inside the bladder, the gel solidifies and forms a drug reservoir. Upon contact with urine, the gel dissolves, release the drug slowly and is finally cleared out from the bladder.

Intravesical MMC instillation using TheraCoat's gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.

1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second cystoscopy to compare to baseline status. The patient will be followed-up for a period of 1 year as follows: 3,6,9,12 months.

Being tested
TC-3 hydrogel
Keywords
Non Muscle Invasive Bladder Cancer, Intravesical instillation, Mitomycin C, Hydrogel, Reverse thermal gelation, Drug retention, Urinary Bladder Neoplasms, Carcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Urinary Bladder Diseases, Urologic Diseases, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type Mitomycins, Mitomycin, Antibiotics, Antineoplastic, Antineoplastic Agents, Therapeutic Uses
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Urinary Bladder Diseases

What participants receive

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

  • TC-3 hydrogelDevice

  • TC-3 hydrogelDevice

  • TC-3 hydrogelDevice

Study groups in NCT01799499
Study groupRoleWhat they receive
Group A: 20 mg MMC mixed with 60cc TC-3ExperimentalGroup A: 20 mg MMC mixed with 60cc TC-3 hydrogel. (n=8)
Receives: Device: TC-3 hydrogel
• Group B: 40 mg MMC mixed with 60cc TC-3Experimental• Group B: 40 mg MMC mixed with 60cc TC-3 hydrogel (n=8)
Receives: Device: TC-3 hydrogel
• Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)Experimental• Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)
Receives: Device: TC-3 hydrogel

What is being measured

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

  1. Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients

    Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients.

    Measured: 2 Years

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability rate.

    Demonstration of Pre-TURBT TC-3 gel-MMC instillation safety and adverse event rate.Adverse events will be defined as any adverse change in health or side effect that occurs in the clinical trial participant while the patient is receiving the treatment or until the completion of the post-treatment follow-up cystoscopy.

    Measured: 2 years

Timeline

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

  1. First posted26 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: Change in the company clinical trials priority

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799499
Sponsor's protocol ID
PRE-TURBT-DR-PRO
Acronym
NMIBC TURBT HG
Status last verified
Aug 2015
First submitted
21 Feb 2013
Last updated
1 Sep 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing TC-3 hydrogel in people with Non Muscle Invasive Bladder Cancer, run by UroGen Pharma Ltd. at 1 site 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 12 inclusion and 27 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: withdrawn, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients (time frame: 2 Years). The study lists 2 primary outcomes in all. 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 NCT01799499.

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 1 Sep 2015; AzTrials last refreshed its copy on 27 Oct 2026.

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