NCT01417403

Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases

A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of hydroxychloroquine in treating patients with solid tumors undergoing radiation therapy for bone metastases. Drugs, such as hydroxychloroquine, may make tumor cells more sensitive to radiation therapy

Detailed description

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.

Conditions

• Bone Metastases
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	hydroxychloroquine	Given PO
RADIATION	radiation therapy	Undergo radiotherapy

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-08-16
• Last updated: 2015-02-03

Locations

1 site across 1 country: United States