NCT02184533

A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer

Completed Phase 1 Last updated 24 May 2024

What this trial tests

Phase 1 trial testing sodium selenite in Adenocarcinoma of the Prostate in 15 participants. Completed in 1 May 2018.

Timeline

1 July 2014

Primary endpoint
1 May 2018

1 May 2018

Quick facts

Lead sponsor	Stanford University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 July 2014
Primary completion	1 May 2018
Estimated completion	1 May 2018
Sites	1 location across United States

Drugs / interventions tested

• sodium selenite (SODIUM SELENITE) — full drug profile →
• radiation therapy — full drug profile →
• laboratory biomarker analysis — full drug profile →
• pharmacological study — full drug profile →
• questionnaire administration

Conditions studied

• Adenocarcinoma of the Prostate — all drugs for Adenocarcinoma of the Prostate →
• Hormone-resistant Prostate Cancer — all drugs for Hormone-resistant Prostate Cancer →
• Recurrent Prostate Cancer — all drugs for Recurrent Prostate Cancer →
• Stage IV Prostate Cancer — all drugs for Stage IV Prostate Cancer →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Adenocarcinoma of the Prostate or Hormone-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: Up to 2 years
  Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selenium Compounds as Novel Potential Anticancer Agents.
   Radomska D, Czarnomysy R, Radomski D, Bielawski K. · · 2021 · cited 97× · PMID 33498364 · DOI 10.3390/ijms22031009
2. Redox signaling in drug-tolerant persister cells as an emerging therapeutic target.
   Zhang Z, Tan Y, Huang C, Wei X. · · 2023 · cited 52× · PMID 36827719 · DOI 10.1016/j.ebiom.2023.104483
3. Necroptosis and Prostate Cancer: Molecular Mechanisms and Therapeutic Potential.
   Beretta GL, Zaffaroni N. · · 2022 · cited 20× · PMID 35406784 · DOI 10.3390/cells11071221
4. Clinical Pharmacokinetics of Oral Sodium Selenite and Dosing Implications in the Treatment of Patients with Metastatic Cancer.
   Jayachandran P, Knox SJ, Garcia-Cremades M, Savić RM. · · 2021 · cited 7× · PMID 33866531 · DOI 10.1007/s40268-021-00340-9
5. Selenium compounds for cancer prevention and therapy - human clinical trial considerations.
   Lü J, Jiang C, Hu H. · · 2025 · PMID 40600186 · DOI 10.1515/mr-2024-0065