Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
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|ClinicalTrials.gov Identifier: NCT01417403|
Recruitment Status : Terminated (Recently published data that has shown HCQ to be safe when combined with chemo and or radiation at even higher doses than what is used in this study.)
First Posted : August 16, 2011
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Unspecified Adult Solid Tumor, Protocol Specific||Drug: hydroxychloroquine Radiation: radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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
- MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy [ Time Frame: 12 weeks ]Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417403
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Laurie Cuttino||Massey Cancer Center|