Know Cancer

or
forgot password

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)


N/A
21 Years
N/A
Not Enrolling
Both
Non Muscle Invasive Bladder Cancer

Thank you

Trial Information

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)


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.


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 diverticulum

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

2 Years

Safety Issue:

No

Authority:

Israel: Ministry of Health

Study ID:

PRE-TURBT-DR-PRO

NCT ID:

NCT01799499

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Non Muscle Invasive Bladder Cancer
  • Non Muscle Invasive Bladder Cancer
  • Intravesical instillation
  • Mitomycin C
  • Hydrogel
  • Reverse thermal gelation
  • Drug retention
  • Intravesical Instillation
  • 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
  • Pharmacologic Actions
  • Nucleic Acid Synthesis Inhibitors
  • Enzyme Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Alkylating Agents
  • Urinary Bladder Neoplasms

Name

Location