Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
3 other identifiers
interventional
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJuly 2, 2015
June 1, 2015
2 years
March 29, 2013
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue pharmacodynamic (PD) response to TORC1 inhibition
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
30 days
Study Arms (2)
Rapamycin
EXPERIMENTALRapamycin 3mg orally daily x 4weeks prior to radical cystectomy
Control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Have invasive (≥T1) bladder cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- In their treating physician's opinion is a good candidate for radical cystectomy
- In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
- Be able to give informed consent
- Be age 18 or older
- 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).
- Have adequate end-organ function (GFR \>30, bilirubin \<1.5, SGOT \< 3x ULN)
- Have a life expectancy \> one year
- Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
- Not have received chemotherapy or radiotherapy in the prior 30 days
You may not qualify if:
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Fixed disease (clinical T4)
- Active, uncontrolled infections
- Hepatic impairment (SGOT \>3x ULN)
- Unhealed wounds
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health Science Center San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert S Svatek, MD,MSCI
UT Health Science Center San Antonio
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Division of Urologic Oncology
Study Record Dates
First Submitted
March 29, 2013
First Posted
April 9, 2013
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
July 2, 2015
Record last verified: 2015-06