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Sodium Selenite

Selenious Acid

Trace Elements

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.

sodium selenite

radiation therapy

laboratory biomarker analysis

pharmacological study

questionnaire administration

Susan Knox

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.

Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer

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

Safety observations and measurements including adverse events, laboratory data, vital signs, and performance status will be summarized.

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.

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.

National Cancer Institute (NCI)

Stanford University

Gland and Hormone Related Diseases

Nervous System Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Peripheral Nervous System Diseases

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neuromuscular Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Selenium

Tubulin Modulators

Antimitotic Agents

The patient will receive an intravenous selenium 2000 μg/40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.

The patient will receive an intravenous normal saline 40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.

High-dose inorganic selenium (2000 μg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.

sodium selenite pentahydrate

Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.

Normal saline

Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.

Chemotherapy

Hee Seung Kim, MD/PhD

This study aims to evaluate the safety and efficacy of high dose inorganic selenium in preventing and relieving chemotherapy-induced peripheral neuropathy (CIPN) in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients. This study will be conducted as a phase III randomized controlled trial in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients who are expected to undergo paclitaxel-carboplatin chemotherapy. A total of 68 patients need to be enrolled in this study. The primary objective of this study is to evaluate the frequency of chemotherapy-induced peripheral neuropathy. The secondary objectives are the evaluation of the severity of peripheral neuropathy and the quality of life to show that selenium is effective in preventing and relieving peripheral neuropathy induced by paclitaxel. Positive results in this study will lead to further studies investigating the effect of selenium on other chemotherapies that can induce peripheral neuropathy.

High-dose selenium is known to reduce systemic inflammatory responses through antioxidant and anti-inflammatory effects. Selenium has also been shown in pre-clinical studies to inhibit chemotherapy-induced peripheral neuropathy through reactive oxygen species mechanisms in cells. Therefore, the investigators aimed to confirm the effect of preventing high dose intravenous selenium prior to chemotherapy and to prevent neuropathy caused by chemotherapy. In this study, the investigators will identify the frequency and severity of CIPN according to World Health Organization (WHO) criteria. Also, the investigators will assess the patient's quality of life (QoL), evaluate the effects of the administration of inorganic selenium on CIPN and QoL, and confirm the safety of high-dose selenium. I would like to.

Patients enrolled in this study will be randomized into two groups. Patients in the control group will receive paclitaxel chemotherapy every 3 weeks for a total of 6 cycles and a dose of normal saline 40 ml every cycle before chemotherapy begins. Patients in the experimental group will receive a dose of selenium 2000 μg/40 ml instead every cycle before chemotherapy.

High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy

Safety and Efficacy of High Dose Inorganic seLenium for Preventing Chemotherapy Induced pEripheral Neuropathy in platINUM Sensitive Recurrent Ovarian, Fallopian, Primary Peritoneal Cancer: Phase III Randomised Controlled Trial

To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.

To evaluate the severity of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.

Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale: 30-126, the higher score means better quality of life

Scoring of quality of life assessment using European Organization for Research and Treatment of Cancer Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-CIPN20) Scale: 20-80, the higher score mean worse symptom

Dosage and usage of concomitant medication (neurontin) for CIPN

Dosage and usage of concomitant medication (duloxetine) for CIPN

Dosage and usage of concomitant medication (celecoxib) for CIPN

Evaluation of chemotherapy-induced toxicity hematologic (ANC, Hb, Plt) and non-hematologic (nausea, vomiting, diarrhea, constipation, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade

Evaluation of any toxicity related to intravenous selenium administration (garlic odor, nausea, vomiting, hypersensitivity reaction) symptoms are evaluated by Common Terminology Criteria for Adverse Events ver 5.0 by grade

Boryung Pharmaceutical Co., Ltd

Seoul National University Hospital

Associate Professor

Disease Progression

In the first part of the study, cohorts of 3 patients receive sodium selenite iv, starting with a dose of 0.5 mg/m2. If no serious adverse event the next cohort is treated according to a dose escalation schedule and this part has been completed. In the modified protocol, a continuous infusion over 2 days will be administered.

Intravenous infusion daily for each week day during 2 weeks (10 infusions). After that chemotherapy during 6 weeks. Chemotherapy for each patients is the first line treatment, so chemotherapy differs among patients, with respect to which treatment a patient got as first line.

Sodium selenite (Introselen)

Intravenous treatment as described above. Cohorts of 3 patient are given a fixed dose for daily treatment (started with 0.5 mg/m2) and if no grade 3 or 4 toxicity, a new cohort is started on a higher dose. The dose for next cohort is 50% higher than for the former cohort. If grade 3 or 4 toxicity is found in 1 patient, 3 more patients are included on the same dose and if one more patient has serious toxicity it is considered to high a dose and a dose in between the toxic dose and the one before is tested. Thus if 2 patients in 3-6 tested patients has serious toxicity by a certain dose, this dose is to high and the highest dose is considered the earlier tested dose.

Sodium selenite

Ola Brodin, MD, PhD

Clara Lenneby-Helleday, MD

In vitro studies have demonstrated that sodium selenite in sufficient concentration and during sufficient time have a high tumoricidal capacity. This is found in many human cell types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of cell lines seem to be resistant. The question from a clinical point of view is: Is it possible with respect to toxicity to administer sodium selenite to patients in sufficient dose and during sufficient time to get responses in patients with cancer? We have performed first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during 12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in vitro data suggest that low concentration of continuous exposure for 51 h is much more effective. Now we are planning to continue the phase-I trial with modified protocol.

More specific:

1. Phase I: Find maximal tolerable dose with continuous infusion
2. Phase II: Use MTD and study responses, if any

* Patients: With advanced malignant disease, any kind, in which all standard treatment has been tried, but still progression. In sufficient good performance status (ps 0-2)to get more treatment: first selenite and immediately afterwards chemotherapy (since an additive or synergistic effect from selenite and chemotherapy has been found).
* Treatment: We have performed the initial study with sodium selenite i.v. daily, 10 treatments during 2 weeks. The week after that response evaluation and then chemotherapy. In each patient, his or her first line chemotherapy treatment is given, since in vitro studies indicate that selenite might reverse resistance. In the modified protocol, a 2 days continuous infusion will be performed.
* Toxicity evaluation (main criteria in phase I): Meeting a doctor once a week during selenite treatment and before each chemotherapy treatment and at End of treatment. Meeting a nurse each treatment day during selenite treatment. Blood samples for liver, kidney, blood and thyroid values. Plasma samples for selenite concentration during treatment.
* Response evaluation (to be: main criteria in phase II and studied also in phase I): CT scan just before and after selenite treatment and after chemotherapy. From May 2011 FDG-PET-CT-scan just before and after selenite treatment. Cytokeratin and cytokeratin fragments evaluation.

Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma

Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma. A Phase I and Phase II Study.

To find which kind and grade of toxicities that are dose-limiting

Responses are measured essentially by CT scan or PET-CT-scan. During the Phase II study, responses are the primary criteria but in the phase I study toxicity is the main criteria.

Cancerfonden

Cancer and Allergy Foundation

Cancerföreningen i Stockholm

Region Stockholm

Karolinska University Hospital

MD, PhD, Ass Prof, Senior consultant

Skin and Connective Tissue Diseases

Breast Neoplasms

Lymphedema

Lymphatic Diseases

Breast Diseases

Skin Diseases

Wilfred Levin, MD

The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.

The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients

Princess Margaret Hospital, Canada

University Health Network, Toronto

Substance Related Disorders

Keratosis, Actinic

Keratosis

Melanosis

Poisoning

Arsenic Poisoning

Precancerous Conditions

Chemically-Induced Disorders

Hyperpigmentation

Pigmentation Disorders

Heavy Metal Poisoning

Syndrome

Neurotoxicity Syndromes

Antioxidants

Protective Agents

Patients who receive treatment (selenium)

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

placebo

Julian E Spallholz, PhD

Paul F La Porte, PhD

Selim Ahmed, MBBS, FCPS

Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(GS)2AsSe\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.

Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.

Selenium in the Treatment of Arsenic Toxicity and Cancers

Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial

Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.

The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.

The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.

American Cancer Society, Inc.

Texas Tech University

Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University.

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Given orally, 5.5 mg selenite with food (within 30 mins of eating), for 5 weeks and monthly there after

Given orally, 11 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after

Given orally, 16.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after

Given orally, 22 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after

Given orally, 27.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after

Given orally, 33 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after

Standard of Care (SOC) abiraterone (Zytiga) as per package insert. The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily.

Susan J Knox

The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.

PRIMARY OBJECTIVE(S):

· To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with abiraterone.

SECONDARY OBJECTIVE(S):

* To assess the safety and tolerability of the combination of sodium selenite and abiraterone in subjects with castration resistant prostate cancer (CRPC)
* To assess the pharmacokinetics of sodium selenite
* To assess changes in Prostate specific antigen (PSA) To evaluate the anti tumor activity of sodium selenite and abiraterone when given in combination as determined by biochemical progression free survival (PFS) and radiographic PFS.

Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone

A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone

Adverse events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5. Dose limiting toxicities (DLTs) of the combination of sodium selenite plus abiraterone are defined as:

* Any ≥ Grade 3 non-hematologic toxicity (possibly, probably, or definitely-related adverse event)
* Any ≥ Grade 3 thrombocytopenia with bleeding
* Any ≥ Grade 4 thrombocytopenia persisting \> 7 days
* Any ≥ Grade 4 neutropenia persisting \> 7 days
* Treatment withdrawal by participant decision, or for safety reasons as deemed necessary by the investigator The DLT outcome will be reported as the number of DLT events by dose cohort occurring within 2 weeks of the beginning of treatment, a number without dispersion.

Participants will be monitored for 12 weeks of treatment, and for 4 weeks subsequent (up to 16 weeks in total), for serious adverse events. The SAE outcome will be reported as the number of SAEs by dose cohort occurring within 16 weeks of the beginning of treatment, a number without dispersion.

Blood levels of sodium selenite (pharmacokinetics) will be assessed at baseline and through 24 hours after the initial dose. The pharmacokinetics outcome will be reported by dose cohort as the mean blood level with standard deviation

Maintenance of prostate-specific antigen (PSA) levels in the blood consistent with disease control can be characterized as biochemical progression free survival (PFS). Blood PSA levels will be measured at baseline through treatment. The outcome will be reported as the PSA level by dose cohort at baseline and at the last assessment within 12 months. The values will be reported as the mean with standard deviation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer	NCT02184533	Adenocarcinoma ... Hormone-resista... Recurrent Prost... Stage IV Prosta... Multiple Myelom... Plasmacytoma	sodium selenite radiation thera... laboratory biom... pharmacological... questionnaire a...	18 Years -	Stanford University
High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy	NCT04201561	Chemotherapy-in... Recurrent Ovari... Ovarian Cancer Fallopian Tube ... Primary Periton...	sodium selenite... Normal saline Chemotherapy	19 Years - 80 Years	Seoul National University Hospital
Sodium Selenite and Radiation Therapy in Treating Patients With Metastatic Cancer	NCT02184533	Adenocarcinoma ... Hormone-resista... Recurrent Prost... Stage IV Prosta... Multiple Myelom... Plasmacytoma	sodium selenite radiation thera... laboratory biom... pharmacological... questionnaire a...	18 Years -	Stanford University
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma	NCT01959438	Malignant Tumor Treatment Resis... Tumor Progressi...	Sodium selenite... Sodium selenite	18 Years -	Karolinska University Hospital
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma	NCT01959438	Malignant Tumor Treatment Resis... Tumor Progressi...	Sodium selenite... Sodium selenite	18 Years -	Karolinska University Hospital
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer	NCT00188604	Breast Neoplasm... Lymphedema	sodium selenite	18 Years -	University Health Network, Toronto
Selenium in the Treatment of Arsenic Toxicity and Cancers	NCT01442727	Arsenical Melan... Arsenical Kerat... Arsenical Cance... Arsenicosis Arsenic Exposur... Arsenic Toxicit... Arsenic Poisoni...	sodium selenite placebo	12 Years - 55 Years	Texas Tech University
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer	NCT00188604	Breast Neoplasm... Lymphedema	sodium selenite	18 Years -	University Health Network, Toronto
Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone	NCT04296578	Prostate Cancer Castrate Resist...	Abiraterone Ace... Sodium Selenite Prednisone	18 Years -	Stanford University

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