Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
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|ClinicalTrials.gov Identifier: NCT04375813|
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-muscle Invasive Bladder Cancer||Drug: eRapa Drug: Placebos||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a multi-site phase II double-blind randomized trial. Subjects will be randomized into placebo arm or intervention arm with low dose (0.5 mg) eRapa (encapsulated rapamycin) Monday-Friday for one year or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for 2 years, then every 6 months for 2 years, then annually following registration. Some patients may also concurrently receive BCG immune therapy maintenance (weekly for 6 weeks for induction period, weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 7 maintenance cycles following tumor removal) per standard of care. Patient-reported outcome assessments, cognitive assessments, and physical assessments will be completed according to the study calendar. Research blood to assess safety, immune response and rapamycin level will be collected regularly throughout the study period. Participants will be followed for up to 4 years following enrollment.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Once the list is generated, a non-study staff member will deliver the list to the designated pharmacist. The pharmacist will follow the generated list in consecutive order of enrollment to determine which group the subject will be assigned. The pharmacist will prepare the correct study drug (Placebo or eRapa (encapsulated rapamycin) 0.5 mg) and label the drug with subject information. Research staff will transport drug from pharmacy to clinic and provide for subject. Randomization will remain double blinded for study staff and subject. Patients will be given a once-daily oral eRapa (encapsulated rapamycin) at 0.5 mg or placebo MF for 1 year. Once the primary objectives have been met (i.e., all participants have completed follow up), the study staff and PI will be unblinded to the randomized study treatment arms. The above mentioned generated randomization list with subject assignments will be provided to the study staff and PI by the designated pharmacist.|
|Official Title:||Phase II Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2029|
Active Comparator: Active Study Drug Group
Patients will be given 0.5mg eRapa (encapuslated rapamycin) orally each weekday (Monday-Friday) for one year.
0.5mg eRapa (encapsulated rapamycin) oral capsules
Other Name: encapsulated rapamycin
Placebo Comparator: Placebo Group
Patients will be given a placebo (visually identical to the eRapa (encapsulated rapamycin)) orally each weekday (Monday-Friday) for one year.
placebo capsules visually identical to eRapa oral capsules
- Determine 1-year Recurrence Free Survival (RFS) rate [ Time Frame: 1 year ]The primary analysis will be the estimation of the RFS rate with the 95% confidence interval and comparison of the rate to the historical rate of 68% using the single arm log-rank test (one-sided alpha = 0.05). If the observed rate of RFS is 80% the expected number of events is about 20-28. Recurrence confirmed by pathologic examination of biopsied tissue.
- Change in Urinary Quality of Life [ Time Frame: Scored at baseline and months 9 and 21. ]Urinary Quality of Life measured using the urinary domain of the QLQ-BLS24 Index (a 24-item questionnaire that measures quality of life as it relates to urinary symptoms, sexual function, and bother domains). QLQ-BLS24 with a scale ranging from 24-96, and higher scores are worse.
- Change in Cognitive Function [ Time Frame: EXIT will be scored at baseline and on months 12, 24, 36, and 48. ]Cognitive function will be measured throughout the study period using EXIT. The EXIT is a brief 25-item interview that will be used by trained research staff to evaluate executive cognitive dysfunction of subjects.
- Change in Cognitive Function [ Time Frame: SLUMS will be scored at baseline and on months 12, 24, 36, and 48. ]Cognitive function will be measured throughout the study period using St. Louis University Mental Status exam (SLUMS). The SLUMS exam will be used to evaluate memory, digit span and animal fluency.
- Change in Cognitive Function [ Time Frame: TAPS will be scored at baseline and on months 3, 6, 12, and 24. ]Cognitive function will be measured throughout the study period using Texas Assessment of Processing Speed (TAPS). The TAPS test will evaluate digit/symbol coding.
- Change in cytoscopy consistent with recurrence (time to recurrence) [ Time Frame: Patients will undergo office-based cystoscopy with urine cytology every 3 months for the first 2 years, then every 6 months for 2 years, then annually until 4 years after the last patient is enrolled, with biopsies per standard of care if necessary. ]Change in cytoscopy results from baseline consistent with recurrence, confirmed by pathologic examination of biopsied tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375813
|Contact: Lauren Zahra, MSfirstname.lastname@example.org|
|Contact: Stephanie Althoffemail@example.com|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Donna Mitchell 214-645-8789 firstname.lastname@example.org|
|Contact: Aphrihl Dennis 214-645-8791 email@example.com|
|Principal Investigator: Yair Lotan, MD|
|UT Health San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Emily Rios 210-567-3224 RiosE3@uthscsa.edu|
|Principal Investigator: Robert S Svatek, MD|
|Principal Investigator:||Robert S Svatek, MD, MSCI||UT Health San Antonio|