Glioblastoma study: Treatment Period
Official title Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
ClinicalTrials.gov ID: NCT05768919
What this study is testing
What is Treatment Period 1?
This is an investigational combination of liposomal curcumin, temozolomide, and radiation being studied for newly diagnosed high-grade gliomas. is designed to deliver curcumin to the body using liposomes, which are tiny fat-based spheres that help carry the medicine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding liposomal curcumin to standard care is safe and if it helps treat the tumor.
- Who it's for
- People recently diagnosed with a high-grade brain tumor called glioblastoma.
- What's involved
- Participants will receive liposomal curcumin along with radiation therapy and a chemotherapy drug called temozolomide.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age
- Histologically confirmed HGG (WHO grade III or IV, including GBM, astrocytoma, gliosarcoma, H3K27M mutant diffuse midline glioma).
- Planning standard therapy with TMZ and XRT for 6 weeks and adjuvant TMZ for six 28-day cycles.
- Hgb \> 9 g/dL
- ANC ≥ 1500/µL
You likely can't join if
- Any concurrent cancer diagnosis that is untreated, actively treated, or has undergone any therapy (XRT, cytotoxic, targeted, immunotherapeutic, etc.)...
- Patient has not recovered from AEs due to prior anticancer therapy (i.e., residual toxicities \> Grade 1), with the exception of alopecia
- Receiving any other investigational agent
- Active infection requiring systemic antibiotics
- History of allergic reaction to compounds that are chemically or biologically similar to LC
- Patient is taking a medication that may potentiate hemolysis
See the full eligibility criteria
- ≥18 years of age
- Histologically confirmed HGG (WHO grade III or IV, including GBM, astrocytoma, gliosarcoma, H3K27M mutant diffuse midline glioma).
- Planning standard therapy with TMZ and XRT for 6 weeks and adjuvant TMZ for six 28-day cycles.
- Hgb \> 9 g/dL
- ANC ≥ 1500/µL
- Platelet count ≥ 100,000/µL
- Total bilirubin ≤ 1.5 \ institutional ULN
- AST and ALT ≤ 3 \ institutional ULN OR
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 unless data exist supporting safe use at lower values of renal function, but eGFR must be ≥ 30 mL/min/1.73 m2
- Patients with human immunodeficiency virus (HIV) who are on effective antiretroviral therapy are eligible if the viral load was assessed as undetectable within 6 months prior to baseline
- Women: WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
- Men: must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of LC administration
- Any concurrent cancer diagnosis that is untreated, actively treated, or has undergone any therapy (XRT, cytotoxic, targeted, immunotherapeutic, etc.) within 2 years of study enrollment, with the exception of squamous or...
- Patient has not recovered from AEs due to prior anticancer therapy (i.e., residual toxicities \> Grade 1), with the exception of alopecia
- Receiving any other investigational agent
- Active infection requiring systemic antibiotics
- History of allergic reaction to compounds that are chemically or biologically similar to LC
- Patient is taking a medication that may potentiate hemolysis
- Unstable angina or myocardial infarction within the past 6 months
- Prolonged QTc interval, Fridericia formula (QTcF) (\> 450 msec for males or \> 460 msec for females)
- Psychiatric illness or social situation that could limit compliance with study requirements
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.