Spots Global Cancer Trial Database for Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

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Trial Identification

Brief Title: Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

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

Study ID: NCT02184533

Conditions

Adenocarcinoma of the Prostate

Hormone-resistant Prostate Cancer

Recurrent Prostate Cancer

Stage IV Prostate Cancer

Multiple Myeloma

Plasmacytoma

Interventions

sodium selenite

radiation therapy

laboratory biomarker analysis

pharmacological study

questionnaire administration

Study Description

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.