Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in the company clinical trials priority
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC-3 hydrogel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A: 20 mg MMC mixed with 60cc TC-3
- description
- Group A: 20 mg MMC mixed with 60cc TC-3 hydrogel. (n=8)
- interventionNames
- Device: TC-3 hydrogel
- type
- EXPERIMENTAL
- label
- • Group B: 40 mg MMC mixed with 60cc TC-3
- description
- • Group B: 40 mg MMC mixed with 60cc TC-3 hydrogel (n=8)
- interventionNames
- Device: TC-3 hydrogel
- type
- EXPERIMENTAL
- label
- • Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)
- description
- • Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patient is 21 years of age or older.
2. Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
3. Single or multiple tumors (n≤7)
4. Naïve or Recurrent tumor
5. No prior history of HG and/or T1 and/or Tis
6. At least one Tumor ≥ 1mm as evaluated visually by the investigator
7. Largest tumor diameter ≤ 30mm as evaluated visually by the investigator
8. Cystoscopic appearance of papillary Low grade tumor
9. The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers.
10. Good performance status (Karnofsky performance status 70% or greater).
11. No active urinary tract infection as confirmed by urine culture.
12. 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.
Exclusion Criteria:
1. Carcinoma In Situ (CIS).
2. Over 7 lesions
3. Lesion is larger than 30mm in diameter.
4. "High Grade" urine cytology.
5. Cystoscopic Appearance suspicious for HG and/or solid and/or Tis
6. histologic results of cold cup biopsy are indicative of HG tumor.
7. Tumor located in prostatic urethra.
8. Previous systemic chemotherapy or pelvic radiotherapy.
9. Pregnant or breastfeeding patient.
10. Previous treatment with BCG within the last 24 months.
11. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening.
12. Treatment with intravesical chemotherapy within the 3 last months.
13. The patient has/had any bladder tumor with histology other than TCC
14. Contraindication to MMC.
15. 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).
16. The patient has a bleeding disorder or a screening platelet count \<50X109/L.
17. The patient has screening hemoglobin \<10mg/dL.
18. The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive.
19. 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.
20. The patient participated in an investigational protocol within the past 90 days.
21. The patient has life expectancy of \<3 years.
22. 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
23. The patient has documented vesica-ureteral reflux or an indwelling ureteral stent
24. The patient has the tumor in the bladder diverticulumReferences
Publications (0)
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