BridgeMD
LSTA1 for subjects with newly diagnosed Glioblastoma Multiforme when added to standard of care (temozolomide) versus temozolomide
EU CTIS ID: 2023-506813-23-00
What this study is testing
To determine the effect of LSTA1 in combination with TMZ on survival relative to matching LSTA1 placebo in combination with temozolomide in patients with newly diagnosed GBM
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent
- Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention)
- Adequate contraception
- Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification
- Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks
- Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks)
You likely can't join if
- Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor
- Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- Patients who received prior Gliadel wafers
- Patients with concurrent stereotactic radiosurgery or brachytherapy
See the full eligibility criteria
- Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent
- Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention)
- Adequate contraception
- Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification
- Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks
- Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks)
- Subjects must be able to undergo serial MRIs (computerized tomography may not be a substitute for magnetic resonance imaging [MRI]).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Life expectancy ≥ 3 months, as determined by the investigator
- Patient may have- or continue to receive corticosteroids, by s/he must be on a stable or decreasing dose for at least 14 days prior to randomization
- Subjects must have adequate organ and marrow function
- Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor
- Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- Patients who received prior Gliadel wafers
- Patients with concurrent stereotactic radiosurgery or brachytherapy
- Patients with extracranial metastatic disease
- Patients with leptomeningeal dissemination
- Progression of GBM during or after the standard-of-care radiotherapy and TMZ 6-week regimen.
- Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1 by MRI. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment
- Participation in another interventional clinical study within the last 1 year
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.