Using encapsulated rapamycin to prevent bladder cancer recurrence

Phase II Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

This study is testing if a new treatment called encapsulated rapamycin can help prevent bladder cancer from coming back in people who have already been diagnosed with it.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (Academic / other)
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT04375813 on ClinicalTrials.gov

What this trial studies

This phase II double-blind randomized controlled trial investigates the efficacy of encapsulated rapamycin (eRapa) for secondary prevention in patients diagnosed with non-muscle invasive bladder cancer (NMIBC). Participants will be randomly assigned to receive either eRapa or a placebo for one year, with regular endoscopic evaluations and assessments of immune response, cognition, and physical function. The study aims to determine if eRapa can reduce the risk of cancer relapse while maintaining quality of life. Participants will be monitored for up to five years post-enrollment to assess long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a recent diagnosis of non-muscle invasive bladder cancer.

Not a fit: Patients with active infections, those on glucocorticoids, or those with other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of bladder cancer recurrence in patients with NMIBC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapeutic approaches, but the use of encapsulated rapamycin is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment
* Able to give informed consent
* 18 years or older
* Patients must not be taking oral glucocorticoids at the time of registration
* Not have active, uncontrolled infections
* No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
* Patients with localized prostate cancer who are being followed by an active survelillance program are also eligible.
* Patients must not be pregnant or nursing, as the use of Intravesical BCG is not recommended during pregnancy. Women/ men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. Examples of effective contraception include hormonal contraception, double barrier method (condom with spermicidal cream, diaphragms with spermicidal cream, or condoms with diaphragms), Intrauterine device, and/or partner vasectomy. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Both male and female patients will be required to disclose contraception method during screening and agree to continue to use that contraception method through the end of their participation in the study.
* Patients must have had all grossly visible papillary tumors removed within 90 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 90 days prior to registration.
* Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days prior to registration. Patients with T1 disease must have re-resection confirming ≤ T1 disease within 90 days prior to registration.
* Patients must no have received prior intravesical BCG

Exclusion Criteria:

* Have muscle-invasive or higher (≥T2) bladder cancer
* Unable to give informed consent
* Age 17 or younger
* Taking oral glucocorticoids at the time of registration
* Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Patients at risk of pregnancy that are unwilling or unable to take effective contraception during the study period, or patients that are nursing during the study period. Women/ Men of reproductive potential must have agreed to use an effective contraceptive method or will be considered ineligible for study participation.
* Evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days prior to registration
* History of prior intravesical BCG
* History of prior Rapamycin treatment

Where this trial is running

Dallas, Texas and 1 other locations

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• UT Health San Antonio — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Robert S Svatek, MD, MSC — The University of Texas Health Science Center at San Antonio
• Study coordinator: Fred Norton, BS

Conditions Non-muscle Invasive Bladder Cancer