A Phase IB Study of Hydroxychloroquine Prior to Nephrectomy in Patients With Primary Renal Cell Carcinoma
Autophagy is a cellular survival mechanism that protects from stress-induced programmed
death. Autophagy may enable renal cancer to escape from cytokine therapy, cytotoxic
chemotherapy or targeted agents. Hydroxychloroquine prevents autophagy by blocking
acidification of lysosomes, and is being studied in clinical trials as a means of enhancing
of cancer therapy. This phase Ib clinical trial will test the hypothesis that pre-operative
exposure to HC reduces biologic markers of autophagy in peripheral blood, normal kidney and
renal cancer specimens obtained at the time of nephrectomy. These data will be used in the
design and pharmacodynamic monitoring of future therapeutic trials of HC in combination with
high dose interleukin-2 and other systemic therapies for advanced RCC.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure biologic markers of autophagy in tumor and normal tissues (peripheral blood mononuclear cells, renal parenchyma) following a short course of pre-operative oral hydroxychloroquine [HC] in patients with renal cell carcinoma.
Pre-hydroxychloroquine (HC), post-HC/pre-nephrectomy, post-nephrectomy (up to 1 month)
No
Jodi K. Maranchie, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
UPCI 10-029
NCT01144169
October 2010
July 2014
Name | Location |
---|---|
UPCI/UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
UPMC Department of Urology | Pittsburgh, Pennsylvania 15232 |