NCT02184533

Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer
• Multiple Myeloma
• Plasmacytoma

Interventions

Type	Name	Description
DRUG	sodium selenite	Given PO
RADIATION	radiation therapy	Undergo radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2014-07-09
• Last updated: 2024-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study