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A Study of Sodium Selenite Followed by Chemotherapy in Patients with Advanced Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at advanced carcinoma, which means cancer that has spread and is at an advanced stage. The treatment being tested is sodium selenite pentahydrate, which is a form of selenium given through an infusion into a vein. Selenium is a mineral that may have effects on cancer cells. The study will also involve giving chemotherapy after the selenium treatment to see if the combination works better than chemotherapy alone.

The purpose of this study is to find the best dose of selenium that can be given safely over 99 hours while producing the best results in treating the cancer. The study will test different doses to see which one gives the best response without causing serious side effects. Patients will receive sodium selenite through a continuous infusion that lasts for 99 hours, which is just over four days. During this time, blood and urine samples will be collected to measure how the body processes the selenium. After the selenium treatment is finished, patients will receive chemotherapy. Scans will be taken before and after the treatments to see if the tumors have responded.

The study will track several things including how well the tumors respond to the selenium treatment and to the chemotherapy that follows, whether patients experience improvement in their symptoms and overall health status, how selenium moves through the body and stays in the blood, and whether there are any side effects from the treatment. Patients participating in this study must have cancer that has continued to grow despite receiving all standard treatments that are normally used for their type of cancer. The study will continue to follow patients over time to see how long they survive after receiving the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Before starting the sodium selenite treatment, a CT scan (a special type of X-ray that creates detailed images of the inside of your body) will be taken to evaluate the size and extent of your tumor.
Blood and urine samples will be collected to establish baseline measurements.
Your physical condition will be assessed using a performance status scale, which measures how the disease affects your daily living abilities.
Step 2
Sodium selenite infusion treatment
You will receive sodium selenite pentahydrate as a continuous intravenous infusion (a slow injection directly into your vein) for 99 hours (approximately 4 days).
The product used is called Selesyn 500 micrograms/10 ml, which is a solution for injection with a concentration of 50 micrograms per milliliter.
The specific dose you receive will be calculated based on your body surface area and measured in milligrams per square meter over the 99-hour period.
During the infusion, blood samples will be collected from your plasma (the liquid part of blood) and red blood cells, as well as urine samples, to monitor selenium and selenite levels in your body.
Your condition will be monitored for any side effects according to a standardized toxicity measurement system.
Your performance status will be assessed during this treatment period.
Step 3
Post-selenite evaluation
After the 99-hour sodium selenite infusion is completed, additional blood and urine samples will be collected to measure selenium and selenite levels.
A CT scan will be performed to evaluate how your tumor has responded to the selenite treatment.
The tumor response will be assessed using specific measurement criteria to determine if the tumor has shrunk, remained stable, or grown.
Your performance status and any changes in disease symptoms will be evaluated.
Laboratory tests, including tumor markers (substances in blood that may indicate cancer activity), will be reviewed to assess any improvements.
Step 4
Chemotherapy treatment
Following the selenite treatment and evaluation, you will receive chemotherapy (medications designed to kill cancer cells or stop them from growing).
The specific chemotherapy regimen will be determined based on your type of cancer and medical condition.
Your performance status will continue to be monitored during chemotherapy treatment.
Step 5
Post-chemotherapy evaluation
After completing chemotherapy, a CT scan will be taken to evaluate how your tumor has responded to the chemotherapy treatment.
Blood tests and other laboratory measurements will be performed to assess any improvements in tumor markers or other abnormal results.
Your performance status and disease symptoms will be evaluated to determine if there has been any improvement.
The tumor response will be measured using the same standardized criteria as before.
Step 6
Long-term follow-up
Your overall survival will be tracked from the first day of selenite treatment onwards.
Continued monitoring will assess your long-term response to the combined treatment approach.

Who can join the trial?

10 criteria

You must have advanced cancer, which means cancer that is at stage III or IV. Stage III means the cancer has spread to nearby tissues, and stage IV means it has spread to distant parts of the body.
If you are a woman who can become pregnant, you must use highly effective birth control methods or choose not to have sexual intercourse during the study. Highly effective birth control includes having a male partner who has had a vasectomy (a surgery to prevent pregnancy), using hormonal birth control such as pills or patches, or having an intrauterine device (a small device placed inside the uterus to prevent pregnancy). Women who cannot become pregnant due to surgery, menopause, or previous chemotherapy can also participate.
Your tumor must be confirmed through histology or cytology, which are laboratory tests that examine tissue or cell samples under a microscope to verify the presence of cancer.
Your cancer must be getting worse even after you have tried all the standard treatments available for your type of cancer.
You must have a WHO performance status of 0, 1, or 2. This is a scale that measures how well you can carry out daily activities. A score of 0 means you are fully active, 1 means you have some restrictions but can do light work, and 2 means you can care for yourself but cannot work.
You must be 18 years old or older.
You must not have received radiation therapy (treatment using high-energy rays to kill cancer cells) or chemotherapy (treatment using drugs to kill cancer cells) for at least 3 weeks before starting this treatment.
You must agree to provide blood and urine samples for routine testing and research purposes.
You must provide written informed consent, which means you must sign a document showing you understand the study and agree to participate.
You must agree to receive the study treatment and attend all follow-up visits at the phase 1 unit at Tema Cancer, Karolinska University Hospital.

Who cannot join the trial?

3 criteria

The study information does not list specific reasons why patients cannot participate in this trial
If you are interested in this study, a doctor will need to check if you meet all the requirements during a medical evaluation
General factors that often prevent participation in cancer trials (studies testing new treatments for cancer) may include having other serious health problems, being pregnant or breastfeeding, or taking certain medications that could interfere with the study treatment

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Verified sites

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Karolinska University Hospital
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Solna, Sweden

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Investigated drugs

Sodium selenite
is a form of selenium that is given through a vein (intravenously) over a period of 99 hours. In this trial, it is being tested to see if it can help treat advanced cancer when used before chemotherapy treatment.
Chemotherapy
refers to cancer-fighting medications that are given after the sodium selenite treatment. These are standard treatments used to kill or slow the growth of cancer cells in patients with advanced cancer.

SODIUM SELENITE PENTAHYDRATE

What is already known about the treatment

Sodium Selenite – Sodium selenite is a form of the mineral selenium that is given through an intravenous infusion (directly into a vein) over a continuous 99-hour period in this clinical trial for patients with advanced cancer. This substance is being studied as an experimental treatment in combination with chemotherapy, and researchers are working to determine the safest and most effective dose that can help fight cancer cells without causing serious side effects. Selenium compounds are believed to work by creating oxidative stress in cancer cells, which damages their internal structures and may help slow down or stop tumor growth. Sodium selenite belongs to the class of trace mineral supplements and is currently under investigation as a potential anti-cancer agent, meaning it has not yet been approved as a standard cancer treatment.

Investigated diseases

Advanced Carcinoma – Advanced carcinoma is a type of cancer that has progressed beyond its initial stage and has grown significantly or spread to other parts of the body. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. When described as advanced, it means the disease has developed to a later stage where the tumor may be larger, has invaded nearby tissues, or has spread to lymph nodes or distant organs. The progression of advanced carcinoma varies depending on the type and location of the original cancer. Patients with advanced carcinoma often experience symptoms related to the tumor's size and location, as well as its effects on surrounding organs and tissues. The disease continues to grow and spread if left without intervention, affecting the body's normal functions.