San Antonio, Texas 78229


Purpose:

This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.


Study summary:

This is a phase Ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. This new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than [the other formulation]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.


Criteria:

Inclusion Criteria: The patient must: - Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance - Be able to give informed consent - Be age 18 or older Exclusion Criteria: - Prostate cancer with a Gleason score >7 - Unable to give informed consent - Age < 18 - Immunosuppressed state (e.g., HIV, use of chronic steroids) - Active, uncontrolled infections - On medications with strong inhibitors or inducers of CYP3A4 and or P-gp. - On agents known to alter rapamycin metabolism significantly (Appendix H) - Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) - Individuals with a reported history of liver disease (e.g., cirrhosis) - Individuals who are not a good candidate for active surveillance in their treating physician's opinion - Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic. - Uncontrolled hypertension. - Individuals that have abnormal screening vital organ function prior to enrollment - Liver Function Test - Bilirubin >2.0 - Alkaline phosphatase >5x upper limit of normal (ULN) - ALT/AST >2x ULN - Complete Blood Count: - WBC elevated above the normal standard per the testing laboratory - Hgb/Hct below the normal standards of the testing lab - Platelets below the normal standards of the testing lab - Total Cholesterol >240 mg/dL - Triglycerides > 200 mg/dL - Serum creatinine >2 and BUN >30 - Urinary protein: proteinuria >1+ on urinalysis or >1 gm/24hr


NCT ID:

NCT03618355


Primary Contact:

Katie Lyon, MS, CCRP
Phone: 210-952-6301
Email: klyon@cancerinsight.com


Backup Contact:

Email: sthomas@cancerinsight.com
Sherri Thomas, RN, BSN
Phone: 210-844-5861


Location Contact:

San Antonio, Texas 78229
United States

Brandi Weaver
Phone: 210-567-0178
Email: weaverb@uthscsa.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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