Clinical trial · Interventional
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
NCT01827618CI-TRIAL-00018444completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Bladder Cancer Stage II | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rapamycin
- description
- Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy
- interventionNames
- Drug: Rapamycin
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Tissue pharmacodynamic (PD) response to TORC1 inhibition
- timeFrame
- 30 days
- description
- PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have invasive (≥T1) bladder cancer 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. In their treating physician's opinion is a good candidate for radical cystectomy 4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy 5. Be able to give informed consent 6. Be age 18 or older 7. Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin \>9.5 gm/dl or platelets more than 100,000 cells/mm3). 8. Have adequate end-organ function (GFR \>30, bilirubin \<1.5, SGOT \< 3x ULN) 9. Have a life expectancy \> one year 10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment 11. Not have received chemotherapy or radiotherapy in the prior 30 days Exclusion Criteria: 1. Immunosuppressed state (e.g. HIV, use of chronic steroids) 2. Fixed disease (clinical T4) 3. Active, uncontrolled infections 4. Hepatic impairment (SGOT \>3x ULN) 5. Unhealed wounds 6. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.