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Study on Adding Zoledronic Acid to Standard Treatment for Patients with Glioblastoma

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What is this study about?

This clinical trial is focused on studying the effects of adding zoledronic acid to the standard treatment for patients with glioblastoma, a type of brain cancer. The treatment being tested is called Zometa, which is a solution given through an intravenous infusion. The main goal of the study is to see if this additional treatment can help improve the overall survival and the time patients live without the disease getting worse.

Participants in the study will receive either the standard treatment for glioblastoma or the standard treatment plus Zometa. The study will monitor how long patients live and how long they remain free from disease progression. The study will also look at the safety and any side effects of the treatment. The trial is designed to be open-label, meaning both the doctors and the participants will know which treatment is being given.

The study will take place over several years, with regular check-ups to assess the health and progress of the participants. The trial aims to provide valuable information on whether adding zoledronic acid to the standard therapy can offer better outcomes for patients with glioblastoma. Participants will be closely monitored for any adverse effects to ensure their safety throughout the study.

1 joining the study

Upon joining the study, participants are required to provide informed consent, confirming their understanding and agreement to comply with the study requirements.

Participants must have completed prior treatments, including surgery or biopsy and radio-chemotherapy, with a minimum 28-day gap before starting the trial.

2 randomization

Participants are randomly assigned to receive either the standard therapy alone or the standard therapy with the addition of zoledronic acid.

This process ensures that each participant has an equal chance of receiving either treatment option.

3 treatment administration

Participants receiving zoledronic acid will be administered Zometa 4 mg/100 ml solution through an intravenous infusion.

The frequency and duration of the administration will be determined by the study protocol and the participant’s response to treatment.

4 monitoring and assessments

Participants will undergo regular monitoring to assess the effectiveness and safety of the treatment.

Assessments will include measuring overall survival and progression-free survival, as well as monitoring for any adverse effects.

5 completion of the study

The study is estimated to conclude by January 3, 2028.

Upon completion, participants will have a final assessment to evaluate the outcomes of the treatment received.

Who Can Join the Study?

  • Participants must be able to give signed informed consent, which means they understand and agree to follow the study’s rules and requirements.
  • Participants must have adequate organ function, which includes:
    • White blood cell count (ANC) higher than 1×109/L
    • Platelet count higher than 100×109/L
    • Liver enzymes (AST and ALT) lower than 3 times the upper limit of normal (ULN)
    • Alkaline phosphatase (ALP) lower than 3 times ULN
    • Hemoglobin level higher than 80 g/L
    • Kidney function (creatinine clearance) more than 60 mL/min
    • Serum bilirubin lower than 1.5 times ULN, except for those with Gilbert syndrome, where it should be lower than 3 times ULN
  • Women of childbearing potential must agree to remain abstinent or use effective contraception during the study and for 90 days after the last dose of study medication. Effective contraception includes methods like tubal ligation, male sterilization, or copper intrauterine devices.
  • Men must agree to remain abstinent or use a condom during the study and for 90 days after the last dose of study medication. They must also refrain from donating sperm during this period.
  • Participants must be 18 years or older at the time of signing the informed consent form.
  • Participants must have a type of brain cancer called IDH negative (wild type) glioblastoma.
  • Participants with multiple tumor areas in different parts of the brain (multicentric) or in the same part of the brain (multifocal) are eligible.
  • Participants must have had surgery or a biopsy of the glioblastoma.
  • Participants must have completed combined radiation and chemotherapy treatment before joining the study, with at least 28 days since the last chemotherapy dose.
  • Participants must have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss, mild nerve pain, joint pain, or other non-risky side effects.
  • Participants must have an ECOG Performance Status of 0, 1, or 2, which means they are fully active or have some limitations but can still care for themselves. A status of 3 is allowed if it is due to permanent brain damage from glioblastoma.
  • Participants must be able and willing to swallow and keep oral medication.

Who Cannot Join the Study?

  • Patients who are not diagnosed with glioblastoma, which is a type of brain cancer, cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Latvia Latvia
Recruiting
02.01.2025

Trial locations

Investigated drugs:

Zoledronic Acid is a medication used in this trial to see if it can help improve survival rates in patients with glioblastoma, a type of brain cancer. It is being added to the standard treatment to see if it can make the treatment more effective. Zoledronic acid is known for its ability to strengthen bones and is often used to treat high calcium levels in the blood or bone problems in cancer patients. In this study, researchers are exploring its potential benefits beyond bone health, specifically in treating brain cancer.

Investigated diseases:

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, it can lead to increased pressure within the skull, causing further neurological symptoms. Glioblastoma is typically characterized by its resistance to standard treatments and its tendency to recur after initial therapy.

Trial ID:
2024-519446-67-00
Protocol code:
PSKUS-GB01
Trial Phase:
Therapeutic exploratory (Phase II)

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