Not yet recruitingRare disease

Study on the Effectiveness of Etoposide Phosphate, Carboplatin, Methotrexate, Rituximab, and Cyclophosphamide in Patients with Primary Central Nervous System Lymphoma

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Primary Central Nervous System Lymphoma (PCNSL). This is a rare form of cancer that occurs in the brain or spinal cord. The study is looking at patients who have been newly diagnosed or have had a relapse, meaning the cancer has returned after treatment. The purpose of the study is to explore the effectiveness of a treatment approach that combines chemotherapy and immunotherapy with a technique to open the blood-brain barrier, which is a protective layer that usually prevents substances from entering the brain.

The treatment involves several medications that are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The medications being studied include Etoposide Phosphate, Carboplatin, Methotrexate, Rituximab, and Cyclophosphamide. These drugs are commonly used in cancer treatment and work in different ways to stop the growth of cancer cells. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The study will follow patients over a period of time to see how many are still alive at 2, 5, and 10 years after starting treatment. It will also look at how well the cancer responds to the treatment and any side effects, especially long-term effects on the nervous system. This information will help doctors understand how effective the treatment is and what side effects might occur, providing valuable insights for future treatment of PCNSL.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of primary central nervous system lymphoma, either newly diagnosed or relapsed after previous treatment.
The assessment ensures the patient meets the age criteria of 18-70 years for certain study groups and 71-75 years for others.
Step 2
Treatment phase
The treatment involves chemoimmunotherapy combined with a procedure to open the blood-brain barrier. This allows medications to reach the brain more effectively.
Medications administered include etoposide phosphate, carboplatin, methotrexate, rituximab, and cyclophosphamide. All are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
The specific dosage, frequency, and duration of each medication are determined by the study protocol and tailored to the patient's condition.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the patient's response to treatment and to manage any side effects. This includes both short-term and long-term follow-up.
The primary goal is to evaluate the number of patients alive at 2, 5, and 10 years after treatment, both for those receiving initial treatment and those with relapsed disease.
Secondary assessments focus on the number of complete and partial responses to treatment, as well as monitoring for any long-term neurological side effects.
Step 4
End of study
The study is estimated to conclude by December 31, 2035. At this point, final data analysis will be conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

The patient must have a **primary brain lymphoma**, which is a type of cancer in the brain. This can be a newly diagnosed condition or a condition that has come back or not responded after treatment with **intravenous chemotherapy**, which is medicine given through a vein to treat cancer.
The disease must be a type called **diffuse large B-cell lymphoma**, which is a specific kind of cancer affecting certain white blood cells.
The patient must be between 18 and 70 years old for certain parts of the study, and between 71 and 75 years old for another part.
The patient must have given **written consent** to participate in the study, meaning they have agreed in writing to be part of the research.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are not able to follow the study procedures or attend follow-up visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.
Patients who have a history of substance abuse or alcohol dependency cannot participate.
Patients who have an active infection that requires treatment cannot participate.

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Verified sites

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Oulu University Hospital
Verified
Oulu, Finland

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Investigated drugs

Chemoimmunotherapy
is a treatment that combines chemotherapy and immunotherapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while immunotherapy helps the immune system to better recognize and attack cancer cells. This combination aims to enhance the effectiveness of treatment for patients with primary central nervous system lymphoma.
Blood-Brain-Barrier Opening
is a technique used to temporarily open the protective barrier around the brain. This allows medications to reach the brain more effectively. In this trial, it is used to improve the delivery of chemoimmunotherapy to the brain, potentially increasing the treatment's effectiveness for patients with central nervous system lymphoma.

What is already known about the treatment

Rituximab – This medication is typically administered intravenously, meaning it is given directly into a vein. Rituximab is well-established in medical literature and is commonly used in the treatment of certain types of cancer, including primary central nervous system lymphoma. It works by targeting a specific protein called CD20 found on the surface of certain immune cells, leading to their destruction. Rituximab is classified as a monoclonal antibody, which is a type of targeted therapy designed to attack specific cells in the body.

Investigated diseases

Primary Central Nervous System Lymphoma – This is a rare type of cancer that starts in the lymphatic cells of the brain or spinal cord. It is a form of non-Hodgkin lymphoma that is confined to the central nervous system. The disease can cause symptoms such as headaches, changes in personality, and neurological deficits depending on the location of the tumor. It progresses by growing and potentially spreading within the central nervous system, leading to increased pressure and damage to brain structures. The disease may initially respond to treatment but can relapse or become resistant over time.