Completed

An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer

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What is being tested

Rapamycin

Drug
Who is being recruted

Neoplasms

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center at San Antonio
Last updated: July 2, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.

NCT01827618
Principal SponsorThe University of Texas Health Science Center at San Antonio
Last updated: July 2, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

11 inclusion criteria required to participate
Be able to give informed consent
Be age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have a life expectancy > one year
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6 exclusion criteria prevent from participating
Active, uncontrolled infections
Fixed disease (clinical T4)
Hepatic impairment (SGOT > 3x ULN)
Immunosuppressed state (e.g. HIV, use of chronic steroids)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy

Group II

No Intervention

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UT Health Science Center San Antonio

San Antonio, United StatesOpen UT Health Science Center San Antonio in Google Maps
CompletedOne Study Center