RECRUITING

Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients

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Conditions

Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCGPhotodynamic TherapyNon-muscle invasive bladder cancer ("NMIBC")Urothelial carcinomaTa bladder cancerT1 bladder cancerUnresponsive/Intolerant to BCG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin ("BCG")-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.

Official Title

A Phase II Clinical Study of Intravesical Ruvidar® in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") or Patients Who Are Intolerant to BCG Therapy ("Study II")

Quick Facts

Study Start:2019-08-30
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03945162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be willing and able to provide a written Informed Consent Form ("ICF") for the Study.
  2. 2. Be \> 18 years of age on day of signing ICF.
  3. 3. Have histologically confirmed NMIBC CIS via biopsy with/without resected papillary disease (Ta, T1) (high grade) using the 2004 World Health Organization ("WHO") / International Society of Urologic Pathology classification system. The most recent cystoscopy / TURBT must have been performed within 12 weeks of the Study Procedure date to confirm: histology, grade and stage.
  4. 4. Intolerant to BCG or considered BCG-Unresponsive, which is at least one of the following:
  5. * At least five of six doses of an initial induction course, plus at least two of three doses of maintenance therapy, or
  6. * At least five of six doses of an initial induction course, plus at least two of six doses of a second induction course.
  7. 5. Are not candidates for cystectomy on medical grounds or refuse radical cystectomy.
  8. 6. Have an Eastern Cooperative Oncology Group ("ECOG") performance score of 0 to 2.
  9. 7. Have satisfactory bladder function. Ability to retain Study Drug for a minimum of 60 minutes.
  10. 8. Are available for the duration of the Study including follow-up (approximately 15 months).
  11. 9. Female patients of childbearing potential must have a negative Human Chorionic Gonadotropin ("HCG") pregnancy test taken during the screening visit and confirmed prior to the Study Procedure.
  12. 10. Female patients of childbearing potential must be willing to use 2 methods of birth control (i.e.: oral contraceptive, pills, diaphragm or condoms) or be surgically sterile, or abstain from heterosexual activity for two weeks after the Study Procedure. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year.
  1. 1. Past or current muscle invasive (i.e.: T2, T3, T4) or metastatic urothelial carcinoma.
  2. 2. Has concurrent extravesical (i.e.: urethra, ureter, renal pelvis, prostate or prostatic ducts) non-muscle invasive transitional cell carcinoma of the urothelium. (confirmed by staging to exclude extravesical disease, which may include radiological imaging and/or biopsy) within 3 months of enrollment:
  3. 3. Active gross hematuria.
  4. 4. Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer or localized prostate cancer under active surveillance with Gleason 6 disease. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower Prostate-Specific Antigen ("PSA") undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.
  5. 5. Have a history or current evidence of any condition, therapy, surgery or laboratory abnormality that, in the opinion of the PI, might confound the results of the study, interfere with the patient's participation in the study, or is not in the best interest of the patient to participate.
  6. 6. Currently receiving treatment with a prohibited concomitant therapy (refer to 12.2.1, Prohibited Medications).
  7. 7. Participated in a study with an investigational agent or device within 1 month from the first dose of current Study Procedure.
  8. 8. Prior treatment with an intravesical chemotherapeutic agent within 1 month of the first dose of current Study Drug, with the exception of a single perioperative dose of chemotherapy immediately post-TURBT (not considered treatment).
  9. 9. Have an active infection requiring systemic therapy, including active or intractable Urinary Tract Infection ("UTI"), not resolved prior to the procedure.
  10. 10. Has any contraindication to general or spinal anesthesia.
  11. 11. Is pregnant or breastfeeding within the projected duration of Study II, starting with the screening visit through to two weeks following the last Study Procedure.

Contacts and Locations

Study Contact

Arkady Mandel, MD, PhD, DSc
CONTACT
416-699-5273
amandel@theralase.com

Principal Investigator

Girish Kulkarni, MD, FRCSC
PRINCIPAL_INVESTIGATOR
University Health Network, Toronto

Study Locations (Sites)

Site 02-012 - University of Chicago
Chicago, Illinois, 60637
United States
Site 02-016 - Urology of Indiana
Greenwood, Indiana, 46143
United States
Site 02-015 - Associated Medical Professionals of New York
Syracuse, New York, 13210
United States
Site 02-017 - Central Ohio Urology Group
Gahanna, Ohio, 43230
United States
Site 02-008 - MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
United States
Site 02-006 - Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Site 02-007 - Urology Associates, P. C
Nashville, Tennessee, 37209
United States
Site 02-010 - Urology San Antonio P. A
San Antonio, Texas, 78229
United States
Site 02-009 - Virginia Urology
Richmond, Virginia, 23235
United States
Site 02-011 - University of Wisconsin Health University Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Theralase® Technologies Inc.

  • Girish Kulkarni, MD, FRCSC, PRINCIPAL_INVESTIGATOR, University Health Network, Toronto

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-30
Study Completion Date2027-12

Study Record Updates

Study Start Date2019-08-30
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Photodynamic Therapy
  • Non-muscle invasive bladder cancer ("NMIBC")
  • Urothelial carcinoma
  • Ta bladder cancer
  • T1 bladder cancer
  • Unresponsive/Intolerant to BCG

Additional Relevant MeSH Terms

  • Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG