Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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

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Invasive Bladder Cancer Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rapamycin

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

Group Type EXPERIMENTAL

Rapamycin

Intervention Type DRUG

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rapamycin

Intervention Type DRUG

Other Intervention Names

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Sirolimus, Rapamune

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No