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Study on LSTA1 and Temozolomide for Patients with Newly Diagnosed Glioblastoma Multiforme

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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 called Glioblastoma Multiforme (GBM). The study is testing a new treatment called LSTA1, which is a special type of protein, to see if it can help patients with newly diagnosed GBM. LSTA1 is given as a powder for injection directly into the bloodstream. The trial will compare the effects of LSTA1 when added to the usual treatment, which includes a medication called Temozolomide, against the effects of Temozolomide alone. Some participants will receive a placebo instead of LSTA1 to help understand the true effects of the new treatment.

The purpose of the study is to determine if adding LSTA1 to the standard treatment can improve survival rates for patients with GBM. Participants in the study will be randomly assigned to receive either the combination of LSTA1 and Temozolomide or Temozolomide with a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure the results are unbiased and reliable.

Throughout the study, participants will undergo regular check-ups and tests, including MRIs, to monitor their health and the progress of the treatment. The study will last for a period of time, and researchers will collect data on overall survival and other health outcomes. The goal is to find out if LSTA1 can provide a significant benefit to patients with GBM when used alongside the current standard of care.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being between 18 and 75 years old, having adequate respiratory and cardiac function, and providing written consent.

    The patient must have a newly diagnosed and confirmed case of glioblastoma multiforme (GBM) and have undergone primary surgical resection followed by standard radiotherapy with temozolomide for six weeks.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: one receiving the experimental drug LSTA1 in combination with temozolomide, and the other receiving a placebo matching LSTA1 with temozolomide.

  3. Step 3

    Treatment phase

    The patient receives LSTA1 through direct intravenous injection or a placebo, depending on the group assignment.

    The patient takes temozolomide orally in the form of 100 mg hard capsules. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    The patient's health and response to treatment are monitored through regular medical assessments, including serial MRIs to evaluate the tumor's status.

    The patient's overall survival and progression-free survival are tracked as primary and secondary endpoints of the study.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 31, 2026. The patient's participation continues until the study's end or until the patient withdraws or is withdrawn for any reason.

Who can join the trial?

11 criteria

  • Participants must be between 18 and 75 years old at the time of screening and must provide written consent to join the study.
  • Participants need to have good lung and heart function. This means their blood oxygen level should be at least 60 mm Hg or 92% when breathing normal air, and their heart test (ECG) should show normal results or changes that are not serious and don't need treatment.
  • Participants must use effective birth control methods.
  • Participants must have a new diagnosis of **glioblastoma multiforme (GBM)**, a type of brain tumor, confirmed by a tissue test according to the 2021 World Health Organization (WHO) guidelines.
  • Participants must have had surgery to remove the tumor, followed by a standard treatment of radiation (60Gy/30 fractions) combined with a drug called temozolomide for 6 weeks.
  • Participants need to have enough time to recover from their surgery, which should be at least 4 weeks.
  • Participants must be able to have regular MRI scans, which are detailed pictures of the brain. CT scans cannot replace MRI scans.
  • Participants should have an **ECOG Performance Status** of 0, 1, or 2. This is a scale that measures how well they can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Participants should have a life expectancy of at least 3 months, as judged by the study doctor.
  • Participants can take or continue taking **corticosteroids**, a type of medication, but the dose must be stable or decreasing for at least 14 days before starting the study.
  • Participants must have healthy organs and bone marrow, which is the soft tissue inside bones that makes blood cells.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of brain tumor other than Glioblastoma Multiforme cannot participate. Glioblastoma Multiforme is a specific type of brain cancer.
  • Patients who are not newly diagnosed with Glioblastoma Multiforme are excluded. This means the study is only for those who have recently found out they have this condition.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medication as required will be excluded.
  • Patients who have other serious health conditions that might interfere with the study treatment or outcomes are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have participated in another clinical trial recently may be excluded to avoid interference with the study results.
  • Patients who have allergies or adverse reactions to the study medication or similar drugs will not be allowed to participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, are excluded.
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Investigated drugs

  • LSTA1

    is an investigational medication being studied for its potential to improve outcomes in patients with newly diagnosed Glioblastoma Multiforme (GBM). It is being tested to see if it can enhance the effectiveness of the standard treatment for this type of brain cancer.

  • Temozolomide

    is a standard chemotherapy medication used to treat Glioblastoma Multiforme (GBM). It works by slowing or stopping the growth of cancer cells in the brain. In this trial, it is used as the standard of care treatment to compare the effects of adding LSTA1.

What is already known about the treatment

LSTA1 – LSTA1 is administered orally and is currently being studied in clinical trials for its potential use in treating Glioblastoma Multiforme, a type of brain cancer. It is in the experimental phase and not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for LSTA1 is to improve survival rates in patients with newly diagnosed Glioblastoma Multiforme when used in combination with the standard chemotherapy drug, temozolomide. At the molecular level, LSTA1 is believed to enhance the effectiveness of temozolomide by modifying the tumor microenvironment, although the exact mechanism is still under investigation. It is classified as an investigational drug in the field of oncology.

Investigated diseases

Glioblastoma Multiforme – Glioblastoma Multiforme is an aggressive type of brain cancer that originates from the supportive tissue of the brain. It is characterized by rapid growth and a tendency to invade nearby brain tissue, making it difficult to treat. The disease often presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor's location. As it progresses, the tumor can cause increased pressure within the skull, leading to more severe symptoms. Glioblastoma Multiforme is known for its ability to recur even after treatment, which complicates management. The progression of the disease is typically fast, with changes in symptoms occurring over weeks to months.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506813-23-00Protocol codeLSTA1-GBM-2A GBMEstimated enrolment40 patientsSponsorTartu University Hospital

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