Spots Global Cancer Trial Database for Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma

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Trial Identification

Brief Title: Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma

Official Title: A Phase IB Study of Hydroxychloroquine Prior to Nephrectomy in Patients With Primary Renal Cell Carcinoma

Study ID: NCT01144169

Conditions

Renal Cell Carcinoma

Interventions

Hydroxychloroquine (HC)

Study Description

Brief Summary: The main goal of this research study is to determine whether treating patients with renal cell cancer with hydroxychloroquine before surgery can make the cancer easier to kill. Another goal is to see how the study drug affects the body's immune cells which fight cancer cells.

Detailed Description: 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.