Invasive Bladder Cancer Stage IIEarly Phase 1NCT01827618
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
A Early Phase 1 study testing Rapamycin in people with Invasive Bladder Cancer Stage II, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Bladder Cancer Stage II
- What is being tested?
- Rapamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
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.
Read the detailed description
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.
- Conditions
- Invasive Bladder Cancer Stage II
- Being tested
- Rapamycin
- Keywords
- bladder, Cancer, Cystectomy, Rapamycin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus, Rapamune
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin | Experimental | Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy Receives: Drug: Rapamycin |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue pharmacodynamic (PD) response to TORC1 inhibition
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Bladder Cancer Stage IIStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Svatek, The University of Texas Health Science Center at San Antonio
- Investigators
- Robert S Svatek, MD,MSCI, Principal investigator, UT Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827618
- Sponsor's protocol ID
- HSC20120135H
- Other IDs
- KL2 TR000118-05/CTSA, KL2TR000118-05
- Status last verified
- Jun 2015
- First submitted
- 29 Mar 2013
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT01827618
- Acronym / sponsor ID
- HSC20120135H
- Conditions
- Invasive Bladder Cancer Stage II
- Keywords
- bladder, Cancer, Cystectomy, Rapamycin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin | Experimental | Drug: RapamycinRapamycin 3mg orally daily x 4weeks prior to radical cystectomy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Fixed disease (clinical T4)
- Active, uncontrolled infections
- Hepatic impairment (SGOT >3x ULN)
- Unhealed wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinAlso: Sirolimus, Rapamune | Drug | Rapamycin |
Primary outcome
Tissue pharmacodynamic (PD) response to TORC1 inhibition
Time frame: 30 days
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Svatek, MD,MSCI principal investigator
UT Health Science Center San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rapamycin in people with Invasive Bladder Cancer Stage II, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue pharmacodynamic (PD) response to TORC1 inhibition (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.