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Carcinoma of Urinary Bladder, SuperficialOPTIMANCT01803295

Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC

A study testing 40 mg MMC gel and 80 mg MMC gel in people with Carcinoma of Urinary Bladder, Superficial, run by UroGen Pharma Ltd. at 13 sites in 4 countries.

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

In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
40 mg MMC gel and 80 mg MMC gel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
13 sitesin 4 countries
Study dates
Jun 2013to Jun 2017
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.
  • Naïve or recurrent low grade (LG) NMIBC tumor
  • Recurrent patients - Single or multiple tumors
  • Naive patients - 2 tumors or above
  • No prior history of HG and/or T1 in the past 5 years.
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  • No prior history of Tis
  • At least one Tumor ≥ 1 mm as evaluated visually by the investigator.
  • Largest tumor diameter ≤ 30 mm as evaluated visually by the investigator
  • Cystoscopic appearance of papillary Low grade tumor
  • No active urinary tract infection as confirmed by urine culture
  • If the patient is a female of childbearing potential , she is using two acceptable \& effective methods of contraception , until 6 months post treatment
  • If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation
  • If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable \& effective methods of contraception until 6 months post treatment.

Who cannot join

  • Carcinoma In Situ (CIS).
  • "High Grade" urine cytology which is conclusive for HG.
  • "High Grade" tumor results in cold cup biopsy.
  • Tumor located in prostatic urethra.
  • Previous systemic chemotherapy in the last 2 years or pelvic radiotherapy.
  • Pregnant or breastfeeding patient.
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  • Previous treatment with BCG within the last 12 months.
  • The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last TURBT to current tumor recurrence.
  • Treatment with full course of intravesical chemotherapy within the 3 last months.
  • The patient has/had any bladder tumor with histology other than TCC.
  • Known contraindication or hypersensitivity to MMC or gel.
  • The patient has a known history of upper urinary tract urothelial carcinoma, or Renal Cell carcinoma or other renal cancer.
  • The patient has a known urinary retention which, according to the investigator's opinion, might lead to avoid patient receiving the treatment.
  • The patient has a bleeding disorder or a screening platelet count <50X109/L.
  • The patient has screening hemoglobin <10 mg/dL.
  • 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 could compromise participation, compliance with scheduled visits and/or completion.
  • The patient participated in an investigational interventional study within the past 90 days.
  • The patient has documented sever vesico-ureteral reflux or an indwelling ureteral stent.
  • The patient has the tumor in the bladder diverticulum.
  • The patient participated in a prior TheraCoat's trial with MMC and TC-3

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Israel7 sites

  • Carmel Medical Center of Haifa, Department of Urology

    Haifa

  • Rambam Health Care Campus

    Haifa

  • Wolfson Medical Center of Holon, Department of Urology

    Holon

  • Meir medical center

    Kfar Saba

  • Galil Maaravi Medical Center of Nahariya, Department of Urology

    Nahariya

  • Rabin Medical Center of Petah Tikva, Department of Urology

    Petach Tikvah

  • Ziv Medical Center

    Safed

Other trials in Israel

Italy3 sites

  • Vita Salute University, San Raffaele Hospital of Milan, Department of Urology

    Milan

  • S. Andrea Hospital of Rome, Department of Urology

    Rome

  • Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

    Salerno

Other trials in Italy

Spain2 sites

  • Fundacio Puigvert

    Barcelona

  • Hospital Universitario Infanta Sofìa of Madrid, Department of Urology

    Madrid

Other trials in Spain

Switzerland1 site

  • Hôpital HUG of Geneva, Department of Urology

    Geneva

Other trials in Switzerland

About this study

Official title: 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)

In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode

The investigators believe that this study is of importance of 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 of 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 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, which might improve the patient's prognostic outcome.
  5. If this experimental treatment will prove to have a better ablative effect, this could be translated to a better prophylactic effect of tumor recurrence.
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 as Mitomycin C (MMC) or BCG. This treatment approach is limited due to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.

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

Prior to instillation, the TC-3 hydrogel, in a liquid state, is mixed with MMC.TC-3 mixed with MMC is instilled to the bladder by a catheter. Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder.

Intravesical MMC instillation using TheraCoat 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 the Baseline status and after that a follow-up period: 3,6,9,12 months.

Being tested
40 mg MMC gel, Standard of care MMC mixed with water, 80 mg MMC gel
Keywords
Non Muscle Invasive Bladder Cancer, Intravesical instillation, Mitomycin C, Hydrogel Reverse thermal gelation, Drug retention, Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases, Mitomycin
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases

What participants receive

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

  • 40 mg MMC gelDevice

    Also called MMC-Gel

    A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder.

  • Standard of care MMC mixed with waterOther

    Standard of care 40mg MMC mixed with water

  • 80 mg MMC gelDevice

    Also called MMC-Gel

    A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder

Study groups in NCT01803295
Study groupRoleWhat they receive
40 mg MMC gelExperimentalDevice: TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 60 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter. Other Name: MMC Gel
Receives: Device: 40 mg MMC gel
Standard of care MMC mixed with waterActive comparator40 mg MMC mixed with 40cc water. Six weekly intravesical instillations of 40 mg of MMC mixed with 40 cc of water will be instilled using catheter
Receives: Other: Standard of care MMC mixed with water
80 mg MMC gelExperimentalDevice: TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 60 cc of TC-3 gel mixed with 80 mg MMC will be instilled using catheter. Other Name: MMC Gel
Receives: Device: 80 mg MMC gel

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 of the treatments on The bladder lesion(s) of NMIBC patients

    Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 40 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients. At To, which is the time of identification of a recurrent tumor by cystoscopy, the number, size and location of the lesions will be documented and photographed. Each tumor size will be evaluated by photographing a ureter catheter adjacent to the tumor. Since the ureter catheter diameter is a pre-known variable, the tumor diameter can be calculated using specific software developed for study purposes. Photography of the tumor with a pre-known diameter ureter catheter will be performed during the same cystoscopy as described above and will be evaluated by a central clinic for uniformity of measurements, and the results of these measurements will serve for the post study evaluation of the change in tumor diameter

    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 posted4 Mar 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2016
  4. Study completionJun 2017

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803295
Sponsor's protocol ID
TAS-4M-CS-0002-0
Acronym
OPTIMA
Status last verified
Jun 2017
First submitted
21 Feb 2013
Last updated
16 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 40 mg MMC gel and 80 mg MMC gel in people with Carcinoma of Urinary Bladder, Superficial, run by UroGen Pharma Ltd. at 13 sites in 4 countries.

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 14 inclusion and 20 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Israel, Italy, Spain, Switzerland. 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 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?

ablative effect of pre-TURBT intravesical instillations of the treatments on The 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 NCT01803295.

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 16 Jun 2017.

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