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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Stanford University, School of Medicine
Stanford, California, United States
MTD defined as the maximum dose at which =< 1 of 3 to 6 subjects in a dose group experience a drug-related dose-limiting toxicity, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0
Time frame: 3 weeks
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.
Time frame: Up to 2 years
Pharmacokinetic (PK) profile
PK parameters will be calculated using non-compartmental and/or compartmental models and PK parameters (if possible, maximum concentration \[Cmax\], time to Cmax, area under the curve during the dosing interval, half-life, oral clearance) will be summarized and presented.
Time frame: Week 1, day 1: at predose; 15 minutes; and at 1, 2, 4, and 24 hours; weeks 2 and 4, day 1: at predose and 1 hour
Overall biochemical response rate
Biochemical response defined as PSA decline \>= 50% from baseline at 8 weeks of therapy and which has been confirmed with a second PSA at \>= 3 weeks later.
Time frame: Up to 11 weeks
Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1
Time frame: Up to 2 years
Response rate (complete response, partial response and stable disease) within the radiation therapy field
Time frame: Up to 2 years
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