This phase I/II trial studies the side effects and best dose of hydroxychloroquine sulfate when given together with transarterial chemoembolization (TACE) and to see how well they work in treating patients with liver cancer that cannot be removed by surgery. Hydroxychloroquine sulfate may help TACE work better by making tumor cells more sensitive to the drugs delivered via TACE. The TACE technique kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Giving hydroxychloroquine sulfate together with TACE may be a better treatment for patients with liver cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02013778.
PRIMARY OBJECTIVES:
I. Determine the dose limiting toxicities and maximum tolerated dose of hydroxychloroquine (HCQ) (hydroxychloroquine sulfate) in combination with TACE. (Phase I)
II. Assess effect of combined HCQ and TACE on the complete response rate to therapy. (Phase II)
SECONDARY OBJECTIVES:
I. Determine rate of late grade 1 or higher liver function test (LFT) abnormalities after continuation of HCQ for 8 weeks post TACE (ie after day 56 of treatment). (Phase I)
II. Assess local progression free survival (LPFS). (Phase II)
III. Assess overall survival of patients receiving combination therapy. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of hydroxychloroquine sulfate followed by a phase II study.
Patients receive hydroxychloroquine sulfate orally (PO) once daily (QD) or twice daily (BID) beginning between day -42 and -28 continuing for 12-15 weeks. Patients undergo transarterial chemoembolization on day 0 and again up to 35 days later.
After completion of hydroxychloroquine sulfate treatment, patients are followed up at 30 days, every 3 months for 6 months, and then periodically thereafter.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorGregory Nadolski
