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Study on Bortezomib and Temozolomide for Patients with Recurrent Grade IV Glioma

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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 brain cancer known as Grade IV recurrent glioma, which includes both glioblastoma and astrocytoma. The study is investigating the use of two medications: Temozolomide and Bortezomib. Temozolomide is a medication that comes in the form of hard capsules and is taken orally, while Bortezomib is given as a solution for injection. The purpose of the study is to assess the safety and effectiveness of using Bortezomib in combination with Temozolomide for treating this type of brain cancer.

The study is divided into two phases. In the first phase, the focus is on understanding how safe and tolerable the combination of Bortezomib and Temozolomide is for patients. This phase will help determine the best dose of each medication when used together. In the second phase, the study will evaluate how effective the combination is in treating the cancer. This includes looking at how long patients live without the cancer getting worse and their overall survival time. The study will involve a total of 63 patients, with 10 in the first phase and 53 in the second phase.

Throughout the study, patients will undergo regular assessments, including MRI scans and neurological exams, to monitor the response of the tumor to the treatment. The study will also explore new markers in the blood and tumor tissue that might indicate how well the treatment is working. The trial aims to provide valuable insights into the potential benefits of combining Bortezomib with Temozolomide for patients with recurrent Grade IV glioma.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    MRI scans are performed to confirm the presence of a recurrent tumor.

  2. Step 2

    Phase IB treatment

    The first phase involves assessing the safety and tolerability of the combination of bortezomib and temozolomide.

    Bortezomib is administered as an intravenous injection. The dosage and frequency are determined based on individual tolerance.

    Temozolomide is taken orally in capsule form. The dosage is adjusted to find the optimal combination with bortezomib.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to assess the body's response to the treatment. This includes blood tests and neurological exams every four weeks.

    MRI scans are performed every 12 weeks to evaluate tumor response.

  4. Step 4

    Phase II treatment

    In the second phase, the focus shifts to evaluating the effectiveness of the treatment combination.

    The same medications, bortezomib and temozolomide, are used, with dosages adjusted based on findings from phase IB.

  5. Step 5

    Ongoing assessments

    Throughout the trial, ongoing assessments are conducted to monitor progression-free survival and overall survival rates.

    Additional MRI scans and neurological exams continue as scheduled to track any changes in the tumor.

  6. Step 6

    Completion of trial

    The trial concludes with a final evaluation of the treatment's impact on the tumor and overall health.

    Participants are provided with a summary of their treatment outcomes and any further recommendations.

Who can join the trial?

28 criteria

  • Must have a confirmed return or worsening of a specific type of brain tumor, shown by an MRI scan within 14 days before joining the study.
  • Must agree in writing to participate in the study and allow collection of tumor and blood samples.
  • Must have a **Karnofsky performance status** of 70% or higher, which means being able to care for oneself and do normal activities.
  • Must have a **white blood cell count** of at least 3,000 per cubic millimeter.
  • Must have an **absolute neutrophil count** of at least 1,500 per cubic millimeter, which is a type of white blood cell important for fighting infections.
  • Must have a **platelet count** of at least 100,000 per cubic millimeter, which helps with blood clotting.
  • Must have a **prothrombin time/international normalized ratio (PT INR)** of less than 1.4, which measures how well blood clots.
  • Must have a **hemoglobin level** of at least 10 grams per deciliter, which is a protein in red blood cells that carries oxygen (blood transfusion is allowed if needed).
  • Must have normal liver function, with certain liver tests (bilirubin, AST, ALT, and alkaline phosphatase) not more than 2.5 times the normal limit.
  • Must have normal **serum potassium** levels.
  • Must have **serum sodium** levels greater than 130 mmol/L.
  • Must have a specific genetic feature called **unmethylated MGMT promoter** in the tumor tissue.
  • Must have an **estimated glomerular filtration rate (GFR)** of at least 60, which measures kidney function.
  • Must have stable or reduced doses of **corticosteroids** for at least one week before joining the study. Other medications for symptoms or complications are allowed.
  • If taking certain anti-seizure medications (EIAED), must switch to other types at least two weeks before joining the study.
  • Use of **heparin**, a blood thinner, is allowed.
  • Must stop other experimental drugs at least 12 weeks before joining the study, unless the previous treatment failed, in which case the time can be reduced to 4 weeks.
  • Must be eligible for standard treatment with **Temozolomide**, a chemotherapy drug, given for 5 days every 4 weeks.
  • Women must have a negative pregnancy test within 14 days before joining the study.
  • Women who can have children must use effective birth control unless they are permanently unable to have children.
  • Men in relationships with women who can have children must agree to use a condom during treatment and for a certain period after the last dose of the study drugs.
  • Must provide a sample of tumor tissue from a surgery.
  • Must be 18 years or older and expected to live for more than 8 weeks.
  • Must have a confirmed return or worsening of the tumor at least 12 weeks after completing radiation therapy.
  • Must have a tumor that can be measured.
  • The tumor must not be suitable for **radiosurgery**, a type of precise radiation treatment.
  • Patients who had radiosurgery before can join the study.
  • If treated with **gammaknife** (a type of radiosurgery), there must be at least one tumor area that can be evaluated outside the treated area, unless 12 weeks have passed since the radiosurgery.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of brain tumor than the one being studied.
  • Patients who have not been pre-treated with Bortezomib before combining it with Temozolomide.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Bortezomib

    is a medication used in this trial to help make cancer cells more sensitive to another treatment. It is given to patients with a specific type of brain cancer called grade-4 glioma. The goal is to see if it can improve the effectiveness of the other medication used in the trial.

  • Temozolomide

    is a chemotherapy drug used to treat certain types of brain tumors. In this trial, it is combined with Bortezomib to see if the combination can better control the cancer. The study aims to find the best dose of Temozolomide when used with Bortezomib and to evaluate how well this combination works in treating the cancer.

What is already known about the treatment

  • Bortezomib

    Bortezomib is administered as an injection, typically given under the skin or into a vein. It is currently being studied in clinical trials for its potential to enhance the effectiveness of other cancer treatments. The main therapeutic indication for Bortezomib in this trial is to treat recurrent grade IV glioma, including glioblastoma. At the molecular level, Bortezomib works by inhibiting proteasomes, which are structures inside cells that break down proteins, leading to cancer cell death. It is classified as a proteasome inhibitor.

  • Temozolomide

    Temozolomide is taken orally in capsule form. It is a well-established medication in the treatment of certain brain cancers, including glioblastoma. In this trial, it is used in combination with Bortezomib to treat recurrent grade IV glioma. Temozolomide works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent.

Investigated diseases

Glioblastoma – Glioblastoma is an aggressive type of brain tumor that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and a tendency to invade nearby brain tissue, making it difficult to treat. Symptoms often include headaches, seizures, and neurological deficits, depending on the tumor's location. The tumor can recur even after treatment, and its progression is typically marked by increased size and worsening symptoms. Glioblastomas are classified as IDH wild-type, which refers to a specific genetic mutation status. This type of tumor is known for its complex and heterogeneous nature, contributing to its challenging management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515142-16-00Estimated enrolment63 patientsSponsorHelse Bergen HF

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