Ongoing Clinical Trials for Pseudomyxoma Peritonei
There are currently 2 clinical trials investigating new treatments for pseudomyxoma peritonei, a rare cancer that causes mucus buildup in the abdomen. These studies are testing different combinations of chemotherapy drugs, cancer vaccines, and immunotherapy medications to help patients with this condition. Trials are taking place in Italy and Norway.
Clinical trial locations
- Italy
- Norway
Study on Capecitabine and Cyclophosphamide for Patients with Large Pseudomyxoma Peritonei Preparing for Surgery and Chemotherapy
This trial, taking place in Italy, is testing a treatment approach for patients who have a large amount of tumor present in their abdomen. The study focuses on using two oral chemotherapy medications before surgery to help shrink the tumor and make complete removal more possible.
Investigational drugs: The trial uses Capecitabine and Cyclophosphamide, both given as tablets. Capecitabine is converted in the body into a substance called 5-fluorouracil, which interferes with how cancer cells make DNA and slows their growth. Cyclophosphamide works by disrupting DNA replication in rapidly dividing cancer cells. Both medications belong to the chemotherapy drug class and aim to reduce tumor size before surgery.
Main goal: The study aims to determine how many patients can achieve complete tumor removal through surgery after receiving this medication combination for six months. The treatment is followed by a surgical procedure called cytoreductive surgery, which removes as much tumor as possible, and then a special chemotherapy called HIPEC that is delivered directly into the abdomen to target any remaining cancer cells. Researchers will also monitor patient safety, quality of life, and use CT scans to track how well the treatment is working.
Who can participate: You may be eligible if you are between 18 and 75 years old, have a confirmed diagnosis, and have a Peritoneal Cancer Index score greater than 28, which indicates a large amount of cancer spread in your abdomen. You need to be able to perform most daily activities and have adequate organ function, including proper kidney function with creatinine clearance greater than 50 mL/min, liver function with bilirubin less than 1.5 times normal, and bone marrow function with adequate blood cell counts. If you can have children, you must use approved birth control methods. You also need to be able to follow study requirements and live close enough to the study site for proper monitoring.
Who cannot participate: You are not eligible if you do not have this specific diagnosis, do not have a high tumor burden, are outside the specified age range, or belong to a vulnerable population that might need special protection.
A study of Pseudovax, molgramostim and tislelizumab combination therapy for patients with pseudomyxoma peritonei cancer
This clinical trial in Norway is testing an innovative approach that combines a cancer vaccine with immunotherapy medications to help the immune system fight cancer cells more effectively. This study is designed for patients whose cancer has come back or cannot be removed by surgery and who have no other treatment options available.
Investigational drugs: The trial uses three medications in combination. Pseudovax is an experimental cancer vaccine that targets specific genetic mutations called GNAS mutations commonly found in this type of cancer. The vaccine trains your immune system to recognize and attack cancer cells carrying these mutations. Molgramostim, also known as GM-CSF, is a protein that stimulates white blood cell production and boosts immune response, helping the vaccine work more effectively. Tislelizumab is an immunotherapy drug that blocks a protein called PD-1, which normally prevents immune cells from attacking cancer cells. By blocking this protein, tislelizumab allows your body’s natural defenses to work more effectively against the disease. Pseudovax and molgramostim are given as injections under the skin, while tislelizumab is delivered through an intravenous infusion directly into your bloodstream.
Main goal: The study aims to evaluate how safe these medications are when used together and how well patients tolerate the treatment. Researchers will measure how the medications activate the immune system by taking blood samples and up to three tissue biopsies during the study. They will also track how long participants remain free from disease progression and monitor overall health throughout the treatment period.
Who can participate: You may be eligible if you are at least 18 years old and have a confirmed diagnosis of cancer that has come back or cannot be surgically removed, with no other treatment options available. Your tumor must have a specific genetic change called GNAS mutation and must be suitable for taking tissue samples. You need to have adequate organ function, including sufficient blood cell counts, normal kidney and liver function, and normal blood clotting. You should be able to perform most daily activities and have a life expectancy of more than 6 months. Women who can become pregnant must have a negative pregnancy test within 48 hours before starting, must not be breastfeeding, and must use effective contraception during the study and for 6 months after. Men must use condoms during sexual activity throughout the study and for 6 months after, and must not donate sperm during this period.
Who cannot participate: You are not eligible if you are over 65 years old, have previously been treated with tislelizumab, have known allergic reactions to any study medications, have active or chronic infections including hepatitis B, hepatitis C, or HIV, or have had other types of cancer in the last 5 years. You also cannot participate if you have severe heart conditions, uncontrolled high blood pressure, significant liver problems, severe kidney disease requiring dialysis, autoimmune diseases, are pregnant or breastfeeding, have mental conditions that could interfere with following study procedures, use medications that suppress the immune system, or have participated in other clinical trials within the last 30 days.
Summary
The two clinical trials for pseudomyxoma peritonei represent different treatment approaches for this rare condition. The Italian study focuses on traditional chemotherapy given before surgery for patients with large tumor burdens, using oral medications to shrink tumors and improve surgical outcomes. This trial is expected to continue until 2029 and targets patients who may be candidates for complete tumor removal.
The Norwegian study takes a more innovative approach by combining a cancer vaccine with immunotherapy, specifically targeting patients whose disease has returned or cannot be surgically removed. This trial is particularly notable for requiring a specific genetic mutation (GNAS) in the tumor and represents a personalized medicine approach. The combination of Pseudovax, molgramostim, and tislelizumab aims to harness the body’s immune system to fight cancer cells.
Both trials have specific eligibility requirements related to age, organ function, and disease characteristics. Patients interested in participating should discuss these options with their healthcare providers to determine which trial, if any, might be appropriate for their specific situation. The geographic locations in Italy and Norway mean that patients would need to be able to travel to these countries and remain close to the study sites for proper monitoring and follow-up.
