Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 6:07 AM
Study NCT ID:
NCT01417403
Status:
TERMINATED
Last Update Posted:
2015-02-03
First Post:
2011-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-02310 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA016059 | NIH | None | https://reporter.nih.gov/quic… | View |