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)

NCT01799499 | Withdrawn

• 1 other identifier: PRE-TURBT-DR-PRO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

1. 1.It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
2. 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. 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. 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. 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. 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

Non Muscle Invasive Bladder Cancer

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; Pharmacologic Actions; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Alkylating Agents

Outcome Measures

Primary Outcomes (2)

• 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.

  2 Years

• 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.

  2 years

Other Outcomes (3)

• Comparison of the cystoscopic and pathological effect between the 3 groups.

  2 Years

• one year tumor recurrence rate

  2 Years

• PK level of MMC-C in blood

  1 Year

Study Arms (3)

Group A: 20 mg MMC mixed with 60cc TC-3

EXPERIMENTAL

Group A: 20 mg MMC mixed with 60cc TC-3 hydrogel. (n=8)

Device: TC-3 hydrogel

• Group B: 40 mg MMC mixed with 60cc TC-3

EXPERIMENTAL

• Group B: 40 mg MMC mixed with 60cc TC-3 hydrogel (n=8)

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)

Device: TC-3 hydrogel

Interventions

TC-3 hydrogel DEVICE

Group A: 20 mg MMC mixed with 60cc TC-3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (1)

Western Galilee Hospital Nahariya

Nahariya, Israel

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Carcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 26, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

IL (1)