Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
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
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases|
- MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (radiosensitization therapy)
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine PO QD or BID. Treatment continues until completion of radiotherapy.
Other Name: HCQRadiation: radiation therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417403
|Contact: Laurie W. Cuttino, MDfirstname.lastname@example.org|
|Contact: Diane Holdford, RNemail@example.com|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Laurie W. Cuttino 804-287-4340 firstname.lastname@example.org|
|Contact: Diane J. Holdford, RN, BSN 804-828-0296 email@example.com|
|Principal Investigator: Laurie W. Cuttino|
|Principal Investigator:||Laurie Cuttino||Massey Cancer Center|