A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases
OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of hydroxychloroquine that can safely be
administered to cancer patients in association with radiation prior to developing this
approach for disease treatment.
OUTLINE: This is a dose escalation study.
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine
orally (PO) once daily (QD) or twice daily (BID). Treatment continues until completion of
radiotherapy.
After completion of study treatment, patients are followed up at 4 weeks.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy
Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
12 weeks
Yes
Laurie Cuttino
Principal Investigator
Massey Cancer Center
United States: Institutional Review Board
MCC-13713
NCT01417403
August 2011
August 2016
Name | Location |
---|---|
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia 23298 |