RecruitMe Clinical Trial

A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer
nab-Rapamycin Treatment for BCG Refractory Bladder Cancer
Sponsor:NIH
Enrolling:Male and Female Patients
IRB Number:AAAK7800
U.S. Government ID:NCT02009332
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information:

The study is part of a research program to assess the efficacy of the drug nab-rapamycin, a biologic mTOR inhibitor. The purpose of the study is to assess the response rate, as well as, the safety of administering nab-rapamycin in combination with gemcitabine directly into the bladder in an effort to treat bladder cancer. The study seeks to determine if instilling this medication into the bladder is efficacious enough in the treatment of urinary bladder cancer to warrant further investigation as a treatment option. The dose of nab-rapamycin for Phase 2 is determined to be 200 mg/week based on results from the Phase 1 study. The dose of gemcitabine will be 2000 mg/week. All patients enrolled in Phase 2 will receive the same amount of study drug. Nab-rapamycin is considered an experimental drug, meaning it has not been approved by the FDA. Although gemcitabine has been approved by the FDA for treatment of several cancers, it is not FDA-approved for bladder cancer.This is a multi-institution study at Columbia University Medical Center and Vanderbilt University Medical Center, funded by the National Institutes of Health (NIH). A maximum of 29 patients will be enrolled in this phase 2 study.

This study is closed
Investigator
Joel DeCastro, MD
You may be eligible for this study

Place Holder




Who Can I Contact?
For more information, please contact:
Research Nurse Navigator
Email: cancerclinicaltrials@cumc.columbia.edu
Phone: 212-342-5162