A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Early Phase 1

Conditions

Bladder Cancer

Treatments

Drug: Sirolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT02753309
HSC20160162H

Details and patient eligibility

About

This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.

Full description

This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
  • In their treating physician's opinion is a good candidate for BCG therapy
  • Be able to give informed consent
  • Be age 18 or older
  • Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
  • Not have active, uncontrolled infections
  • Not be on agents known to alter rapamycin metabolism significantly
  • Not have a reported history of liver disease (e.g. cirrhosis)
  • Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
  • Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.

Exclusion criteria

  • Have muscle-invasive (≥T2) bladder cancer
  • Unable to give informed consent
  • Age < 18
  • Immunosuppressed state (e.g. HIV, use of chronic steroids)
  • Active, uncontrolled infections
  • On agents known to alter rapamycin metabolism significantly
  • Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
  • Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
  • Individuals with a reported history of liver disease (e.g. cirrhosis)
  • Individuals who are not a good candidate for BCG in their treating physician's opinion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 3 patient groups

Rapamycin 0.5mg
Active Comparator group
Description:
Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days
Treatment:
Drug: Sirolimus
Rapamycin 2.0mg
Active Comparator group
Description:
Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days
Treatment:
Drug: Sirolimus
Control
No Intervention group
Description:
Subject will be apart of the control group and won't take the study drug being tested

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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