Rapamycin in Advanced Cancers
This study has been completed.
Information provided by (Responsible Party):
Ezra Cohen, MD, University of Chicago
First received: June 26, 2008
Last updated: October 9, 2012
Last verified: October 2012
The goal of this study is to determine the rapamycin dose equivalent to the recommended phase II/III dose of temsirolimus and determine the observed toxicities and anti-tumor response of rapamycin in patients with advanced cancers.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase Ib Study of Rapamycin (Sirolimus) in Patients With Advanced Malignancies
Primary Outcome Measures:
- Dose level equivalent to recommended phase 2/3 dose of temsirolimus [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- observed toxicities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- anti-tumor effect [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Rapamycin given once weekly in escalating doses. Higher dose levels will be split with the half the dose given on day 1 and half the dose on day 2 (24 hours later).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Not recovered from adverse events due to agents administered more than 4 weeks earlier.
- May not be receiving any other investigational agents.
- Uncontrolled brain metastases or malignancy. Patients with brain metastases or a malignant primary brain tumor must have stable neurologic status following local therapy (surgery or radiation) for at least 8 weeks from definitive therapy, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients cannot be receiving enzyme inducing anti-convulsants.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of interstitial lung disease (including pneumonitis, bronchiolitis obliterans with organizing pneumonia, or pulmonary fibrosis) or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with severe immunodeficient states (as judged by the treating physician.
- Pregnant women, breast-feeding must be stopped
- HIV-positive patients are excluded due to possible pharmacokinetic interactions with rapamycin.
- Concurrent use of ketoconazole, cyclosporine, tacrolimus, and rifampin with rapamycin is not permissible. Concurrent use of rapamycin with diltiazem is allowed but should be done with caution or avoided.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707135
|University of Chicago
|Chicago, Illinois, United States, 60637 |
University of Chicago
No publications provided
||Ezra Cohen, MD, Associate Prof., Fellowship Director, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 26, 2008
||October 9, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 12, 2013
Physiological Effects of Drugs