MedTrace Logo

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.

NCT03335059 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-04-15

No results posted yet for this study

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. 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.

Conditions

  • Bladder Cancer
  • Bladder Neoplasm
  • Bladder Tumors
  • Cancer of Bladder
  • Cancer of the Bladder
  • Malignant Tumor of Urinary Bladder
  • Neoplasms, Bladder
  • Urinary Bladder Cancer
  • Carcinoma in Situ of Bladder
  • Papillary Carcinoma of Bladder (Diagnosis)
  • BCG-Unresponsive Bladder Cancer

Interventions

COMBINATION_PRODUCT

Synergo® RITE + MMC

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

Sponsors & Collaborators

  • Medical Enterprises Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael A O'Donnell, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2020-02-26
Completion
2020-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335059 on ClinicalTrials.gov