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Study of Meclofenamate Sodium and Temozolomide for Patients with Progressive MGMT-Methylated Glioblastoma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study is investigating the effects of a medication called meclofenamate sodium, which is taken in capsule form. This medication is being tested in combination with another drug called temozolomide, which is already used as a standard treatment for glioblastoma. The purpose of the study is to determine how safe and effective meclofenamate sodium is when added to the standard treatment with temozolomide.

The study is divided into two phases. In the first phase, the focus is on understanding the safety of meclofenamate sodium and finding the best dose to use. Participants will take the medication and be monitored for any side effects. In the second phase, the study will look at how well the combination of meclofenamate sodium and temozolomide works in treating glioblastoma. Participants will continue to take the medication and have regular check-ups to see how the treatment is affecting their cancer.

Throughout the study, participants will take the medications orally, meaning they will swallow the capsules. The study will last for several months, and participants will have regular visits with their healthcare team to monitor their health and the progress of their treatment. The goal is to find out if adding meclofenamate sodium to the standard treatment can help improve outcomes for people with glioblastoma.

1 Phase I: Initial Treatment

The initial phase involves determining the safety of meclofenamate sodium when used with temozolomide. The goal is to find the appropriate daily dose of meclofenamate sodium for the next phase.

During this phase, the patient will take meclofenamate sodium orally in capsule form. The specific dosage will be adjusted based on the patient’s response and any side effects experienced.

The patient will also continue taking temozolomide as part of their standard treatment. This medication is also taken orally.

2 Phase I: Monitoring and Assessment

The patient will be monitored for any dose-limiting toxicities over the first 8 weeks (56 days) of treatment with meclofenamate sodium.

Progression-free survival (PFS) will be measured from the start of the trial until any signs of disease progression are detected through MRI scans.

3 Phase II: Efficacy Evaluation

In this phase, the focus shifts to evaluating the effectiveness of meclofenamate sodium in combination with standard therapy.

The patient will continue taking the determined dose of meclofenamate sodium along with temozolomide.

4 Phase II: Monitoring and Quality of Life Assessment

The patient’s progression-free survival will be assessed from the day of randomization until any disease progression is confirmed by MRI.

Overall survival will be measured from the day of randomization. Safety and any adverse effects will be continuously monitored.

The patient’s quality of life and cognitive function will be evaluated throughout the trial using the Karnofsky performance score and Mini Mental State Examination.

Who Can Join the Study?

  • The patient must have experienced their first return of the disease after initial treatment with radiation therapy and a specific type of chemotherapy, with more than 3 months since the last chemotherapy and more than 6 months since the end of radiation therapy. No new drug or radiation treatment for the return of the disease should have started yet.
  • The patient must show signs of tumor growth according to specific medical guidelines known as RANO criteria.
  • The patient must provide written consent to participate in the study.
  • The patient must be mentally capable of understanding the reasons and requirements for the study treatment and procedures.
  • The patient must have a specific type of brain tumor confirmed by examining tissue from the initial surgery or, for Phase II, the most recent surgery. This includes a tumor with a certain genetic feature called MGMT promotor-methylated and another feature called IDH wildtype.
  • The patient must be older than 18 years.
  • The patient must have a Karnofsky performance score of 60% or higher, which is a way to measure their ability to perform daily activities.
  • The patient must have a life expectancy of more than 6 months.
  • The patient must have a sufficient number of white blood cells and platelets, which are important for fighting infections and blood clotting.
  • The patient must have proper liver function, with specific levels of bilirubin and liver enzymes (ASAT/ALAT) within acceptable limits, and normal kidney function.
  • The patient must be able to follow the study requirements and live close enough to the study site for regular follow-up visits.
  • Male and female patients who can have children must use an approved method of birth control during the study and for 3 months after it ends.
  • Female patients who can have children and have not yet gone through menopause must have a negative pregnancy test before starting treatment.
  • For Phase II only: The patient must not have had surgery for the first return of the disease yet, and it must be agreed by the medical team that surgery can be safely delayed until 7-10 days after starting the study treatment.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than glioblastoma cannot participate. Glioblastoma is a specific type of brain cancer.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have a history of allergic reactions to the study medications are excluded. This means if you have had a bad reaction to similar drugs before, you cannot join.
  • Patients who are currently participating in another clinical trial are not allowed to join this one.
  • Patients with serious medical conditions that could interfere with the study are not eligible. This means if you have other health problems that might affect the study results, you cannot participate.
  • Patients who are unable to follow the study procedures or instructions are excluded. This means if you cannot understand or follow what the study requires, you cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
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Uynhcsictc Hqembxsg Cjcehub Cologne Germany
Ucsbpuazxqhzvpxfofdlg Mqaeedwu Afn Munster Germany
Gyxspa Uwuzgovmyk Fjwahionx Frankfurt Germany
Kmqaohgj dil Uloznvrhzfqo Mggvtotd Azj Munich Germany

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Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
11.04.2022

Trial locations

Investigated drugs:

Meclofenamate Sodium is being tested in this trial to see if it can help treat a type of brain cancer called glioblastoma. Researchers want to find out if adding this medication to the usual treatment can make it more effective. They are also checking to see if it causes any side effects.

Temozolomide is a standard medication used to treat glioblastoma. It works by slowing or stopping the growth of cancer cells. In this trial, it is used as a part of the standard treatment to see if adding meclofenamate sodium can improve outcomes for patients.

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor’s location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may appear. Glioblastoma is characterized by its tendency to recur even after treatment, making it a challenging condition to manage. The progression of the disease is often monitored through imaging techniques like MRI to assess changes in tumor size and spread.

Trial ID:
2024-511264-89-00
Protocol code:
NEU-201901
Trial Phase:
Therapeutic exploratory (Phase II)

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