Study of Liposomal Curcumin with Radiation and Temozolomide for High-Grade Gliomas
This study is testing a new combination treatment for newly diagnosed high-grade gliomas (a type of brain tumor). It combines Liposomal Curcumin (LipoCurc), a form of curcumin, with standard treatments: radiation therapy (RT) and Temozolomide (TMZ), a chemotherapy drug. Researchers want to see how safe and tolerable this combination is, and how well it works. They will also determine the best dose of LipoCurc to use. You may be eligible if you are 18 or older and have a newly diagnosed high-grade glioma. The study aims to enroll up to 30 participants.
- Study design
- This is a single-center, open-label study with a dose-escalation design. It plans to enroll up to 30 participants.
- What's involved
- You would receive weekly intravenous (IV) infusions of LipoCurc for at least 34 weeks, along with standard radiation and TMZ therapy. Treatment continues until disease progression, safety concerns, or if you choose to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured at 10 weeks and for the duration of treatment, with a minimum of 34 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Matthias Holdhoff, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
- Peter Sordillo, MD, PhD · STUDY_DIRECTOR · SignPath Pharma
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- The number of observed Dose Limiting Toxicity (DLTs)10 weeks
The MTD/RP2D of LC in combination with XRT and TMZ and adjuvant TMZ in newly diagnosed HGG will be determined by recording the number of observed dose limiting toxicities (DLTs). DLTs, as defined in this study occur if in the first three patients entered at a dose-level, more than one of these 3 experiences a serious adverse event, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. If one of the first three patients entered at the level experiences an SAE (as defined by NCI CTCAE Version 5), then three additional patients are entered at that same dose level. If one of the additional three patients experiences an SAE (as defined by NCI CTCAE Version 5), the dose is not advanced beyond that level.
- The number of observed Dose Limiting Toxicity (DLTs)The duration of treatment for each patient, minimum of 34 weeks
The safety and tolerability of LC infused IV over 3 hours will be assessed by recording the number of observed DLTs. DLTs, as defined in this study occur if in the first three patients entered at a dose-level, more than one of these 3 experiences a serious adverse event, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. If one of the first three patients entered at the level experiences an SAE (as defined by NCI CTCAE Version 5), then three additional patients are entered at that same dose level. If one of the additional three patients experiences an SAE (as defined by NCI CTCAE Version 5), the dose is not advanced beyond that level.