Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-27 @ 9:57 AM
Study NCT ID:
NCT02184533
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the maximum-tolerated dose (MTD) of sodium selenite when administered in combination with radiation therapy to subjects with metastatic cancer based on safety and tolerability.
Detailed Description:
Primary Objectives:
* To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with palliative radiation therapy
* To assess the safety and tolerability of the combination of sodium selenite and palliative radiation therapy in metastatic cancer
Secondary Objectives:
* To assess the pharmacokinetics of sodium selenite
* To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy when given in combination
OUTLINE:
Patients receive sodium selenite orally (PO) 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
* To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with palliative radiation therapy
* To assess the safety and tolerability of the combination of sodium selenite and palliative radiation therapy in metastatic cancer
Secondary Objectives:
* To assess the pharmacokinetics of sodium selenite
* To evaluate the anti tumor activity of sodium selenite and palliative radiation therapy when given in combination
OUTLINE:
Patients receive sodium selenite orally (PO) 2 hours before daily radiation therapy treatments. Treatment continues for the duration of the course of radiation therapy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2014-01361 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| PROS0047 | OTHER | OnCore | View | |
| P30CA124435 | NIH | None | https://reporter.nih.gov/quic… | View |