A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (sodium selenite and 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.
Intervention: radiation therapy (Radiation)
Treatment (sodium selenite and 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.
Intervention: sodium selenite (Drug)
Treatment (sodium selenite and 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.
Intervention: laboratory biomarker analysis (Other)
Treatment (sodium selenite and 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.
Intervention: pharmacological study (Other)
Treatment (sodium selenite and 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.
Intervention: questionnaire administration (Other)
Outcomes
Primary Outcomes
Safety and tolerability of the combination using the NCI Common Toxicity Criteria v4.0 grading system for adverse events
Time Frame: Up to 2 years
Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.
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
Secondary Outcomes
- 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)
- Overall biochemical response rate(Up to 11 weeks)
- Tumor responses within the radiation therapy field, assessed using Response Evaluation Criteria in Solid Tumors 1.1(Up to 2 years)
- Response rate (complete response, partial response and stable disease) within the radiation therapy field(Up to 2 years)