Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

Phase 1

Completed

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

Interventions: Drug: sodium selenite
Radiation: radiation therapy
Other: laboratory biomarker analysis
Other: pharmacological study
Other: questionnaire administration

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment (sodium selenite and radiation therapy)	sodium selenite	Patients receive sodium selenite 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.
Treatment (sodium selenite and radiation therapy)	radiation therapy	Patients receive sodium selenite 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.
Treatment (sodium selenite and radiation therapy)	laboratory biomarker analysis	Patients receive sodium selenite 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.
Treatment (sodium selenite and radiation therapy)	pharmacological study	Patients receive sodium selenite 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.
Treatment (sodium selenite and radiation therapy)	questionnaire administration	Patients receive sodium selenite 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.

Primary Outcome Measures

Name	Time	Method
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	3 weeks
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events	Up to 2 years	Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.

Secondary Outcome Measures

Name	Time	Method
Response rate (complete response, partial response and stable disease) within the radiation therapy field	Up to 2 years
Pharmacokinetic (PK) profile	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	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.
Overall biochemical response rate	Up to 11 weeks	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.
Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1	Up to 2 years

Locations (1): Stanford University, School of Medicine
🇺🇸
Stanford, California, United States