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AzTrials

Bladder CancerPhase 3RITE-USANCT03335059

Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.

A Phase 3 study testing Synergo® RITE + MMC in people with Bladder Cancer and Bladder Neoplasm, run by Medical Enterprises Ltd. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Bladder Neoplasm, Bladder Tumors
What is being tested?
Synergo® RITE + MMC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
4 sitesUnited States
Study dates
4 Apr 2019to 26 Feb 2020
Phase
Phase 3
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 current CIS of the bladder, with or without coexisting papillary Ta/T1 NMIBC tumor(s), who experienced an occurrence or recurrence of CIS within 12 months of completion of adequate BCG7 therapy. An adequate BCG regimen shall consist of at least 2 courses of BCG where the first course (induction) must have included at least 5 of 6 weekly treatments and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance, (at least 2 of 3 treatments) administered on a schedule similar to the SWOG 8507 study regimen.
  • All clinical, intra-operative and pathological items for the AUA risk stratification must be documented. This includes bladder mapping, according to the instructions specified in the protocol. With regard to BCG and/or other NMIBC treatments documentation must include:
  • Date of initial treatment,
  • Date of last treatment,
  • The number of courses administered and the number of treatments administered in each course.
  • Patients with concomitant papillary tumor(s) must have undergone a repeat TUR 2-4 weeks prior to the first study treatment:
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  • if the previous TUR was incomplete,
  • if there was no muscle in the specimen after the initial TUR (except in TaLG tumors),
  • in all T1,
  • in all HG tumors ≥ 3cm.
  • CT-IVU or MRI-IVU or IVU/retrograde confirmation of absence of tumor(s) in the upper tract, kidney and ureters performed within 6 months before the study treatment initiation, in selected cases, as recommended in latest AUA guidelines published prior to screening. If IVU/retrograde protocol is not available or contrast allergy/poor renal function preclude such imaging, then non-contrast CT or MRI of the abdomen/pelvis within the same timeframe will suffice.
  • Visual inspection to exclude urothelial carcinoma (UC) in the urethra during cystoscopy.
  • Biopsy of the prostatic urethra, prior to enrollment, to exclude UC of the prostatic urethra, in male patients with:
  • tumor of trigone,
  • tumor of bladder neck, or
  • abnormal prostatic urethra
  • prior history of prostatic urethral involvement.
  • All patients must have urine cytology collected from either voided urine or bladder wash within the screening period prior to enrollment. Patients with positive cytology must also have selective cytology from the upper tract and prostatic urethral biopsies collected within the same period. Patients with a localizing positive upper tract cytology are excluded from the study until definitive treatment renders them free of disease visually and/or radiographically and cytologically (nephroureterectomy, distal ureterectomy or upper tract therapy).
  • Age ≥ 18 yrs.
  • No evidence of urothelial cancer in either kidneys or ureters.
  • Pre-treatment hematology and biochemistry values within the limits:
  • Hemoglobin ≥ 10 g/dl (g/100 ml)
  • Platelets ≥ 150 x 10^9/L (x 10^3/mm^3)
  • WBC ≥ 3.0 x 10^9/L (x 10^3/mm^3)
  • ANC ≥ 1.5 x 10^9/L (x 10^3/mm^3)
  • Serum creatinine < 2 mg/dl
  • SGOT < 1.5 x ULN
  • SGPT < 1.5 x ULN
  • Alkaline phosphatase < 1.5 x ULN
  • Negative pregnancy test for women of childbearing potential.
  • A life expectancy at least of the duration of the study.
  • Signed informed consent.

Who cannot join

  • Non-UC tumor of the urinary tract.
  • Upper tract and/or intramural tumors (e.g., in ostium).
  • Positive selective cytology from the upper tract.
  • History of stage > T1 UC.
  • Papillary tumors > T1 in repeat TUR.
  • Known or suspected reduced bladder capacity. Patients will have an ultrasonic estimation of maximum bladder capacity or void spontaneously the maximum they can retain in their bladder, and this will be used to determine urine volume. A minimum volume of 250 ml is required.
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  • Patients with severe bladder outlet obstruction not adequately controlled with medication (AUA symptom score ≥ 20).
  • Bleeding disorder.
  • Gross hematuria within the past 2 weeks before treatment start.
  • Lactating women.
  • Women of childbearing potential unwilling or unable to use adequate contraception if sexually active.
  • More than low-dose methotrexate (>17.5 mg once a week).
  • Other malignancy within the past 5 years, except: non melanomatous skin cancer cured by excision, surgically treated carcinoma in situ of the cervix or ductal CIS (DCIS)/lobular CIS (LCIS) of the breast or stable prostate cancer (under active surveillance or hormone control) with a life expectancy of more than 5 years.
  • Any known allergy (e.g., to MMC) or adverse event that would prevent a prospective study participant from receiving the study treatment.
  • Known untreated urethral strictural disease or bladder neck contracture or any other condition that may prevent catheterization with a 21F catheter. Patients may undergo dilation or urethral incision before entering the study.
  • Bladder diverticulum with diameter > 1cm, as determined by CT or cystography
  • UTI at any time within 3 weeks before study treatment initiation.
  • Significant urinary incontinence (spontaneous, requiring use of > 1 pad/day (PPD)).
  • History of pelvic irradiation.
  • Patients with electronic devices implanted in abdominal cavity.
  • Participation in another study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients With or Without Papillary NMIBC

This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. The study will also explore progression-free survival time, bladder preservation rate, and overall survival time.

The study will address an unmet need to identify a treatment effective in both ablating the disease and providing a prolonged disease-free period for patients. Ideally, the treatment will delay progression to invasive disease, thus preserving the bladder.

Being tested
Synergo® RITE + MMC
Keywords
BCG, Bacillus Calmette-Guérin, CIS, BCG-unresponsive, Synergo, chemohyperthermia, thermochemotherapy, RF, radio frequency, RITE
Medical subject headings
Urinary Bladder Neoplasms, Disease

What participants receive

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

  • Synergo® RITE + MMCCombination product

    Also called radiofrequency hyperthermia with mitomycin C, RF hyperthermia with mitomycin C, thermochemotherapy, chemohyperthermia

    Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC

Study groups in NCT03335059
Study groupRoleWhat they receive
Synergo® RITE + MMCExperimentalBladder radiofrequency-induced hyperthermia will be delivered in combination with each instillation of MMC in accordance with the Sponsor operational guidelines.
Receives: Combination Product: Synergo® RITE + MMC

What is being measured

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

  1. complete response rate (CRR)

    • no CIS
    • no papillary HG tumor
    • no papillary T1 tumor
    • no extra-vesical UC tumor
    • no progression a patient will be considered a complete responder only if all the criteria above are met.

    Patients experiencing a new occurrence of a benign tumor or low-grade Ta will be allowed to continue in the study (tumor will be resected); such an occurrence will not constitute an event in the primary analysis.

    Patients with tumors of the ostium and/or upper tract and/or prostatic urethra will be considered to have achieved a complete response in the primary analysis but will be removed from the study.

    Measured: 3 months after the initiation of study therapy

Secondary outcomes (1)

  1. disease-free duration of complete response (DCR)

    time of recurrence for complete response patients from the 3-month visit until the time of recurrence or until the last follow-up, whichever occurs sooner.

    Measured: through study completion, up to 33 months

Timeline

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

  1. First posted7 Nov 2017
  2. Study start4 Apr 2019
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Why it stopped: poor enrollment

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335059
Sponsor's protocol ID
RITE-1
Acronym
RITE-USA
Status last verified
Apr 2020
First submitted
30 Oct 2017
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Synergo® RITE + MMC in people with Bladder Cancer and Bladder Neoplasm, run by Medical Enterprises Ltd. at 4 sites in United States.

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 32 inclusion and 21 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: stopped early, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: poor enrollment). Results are not available in the source record.

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?

complete response rate (CRR) (time frame: 3 months after the initiation of study therapy). 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 NCT03335059.

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 15 Apr 2020.

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