NCT05768919 Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
| NCT ID | NCT05768919 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | SignPath Pharma, Inc. |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-03-03 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) in patients with newly diagnosed High-Grade Gliomas (HGG).
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age 2. Histologically confirmed HGG (WHO grade III or IV, including GBM, astrocytoma, gliosarcoma, H3K27M mutant diffuse midline glioma). Patients with methylated or unmethylated O(6)-methylguanine-DNA methyltransferase (MGMT) promoter are eligible, as are IDH WT and mutant patients as long as the treatment plan is for combined XRT/TMZ. The neuropathologic diagnosis of HGG will be made at the respective institution. If any question arises regarding the accuracy of the neuropathologic diagnosis, slides (and pathological blocks, if necessary) will be centrally reviewed 3. Planning standard therapy with TMZ and XRT for 6 weeks and adjuvant TMZ for six 28-day cycles. 4. Karnofsky Performance Scale (KPS) ≥ 70% Adequate organ and marrow function defined as: * 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 5. 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 6. 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 7. 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 Exclusion Criteria: 1. 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 basal cell skin cancer 2. Patient has not recovered from AEs due to prior anticancer therapy (i.e., residual toxicities \> Grade 1), with the exception of alopecia 3. Receiving any other investigational agent 4. Active infection requiring systemic antibiotics 5. History of allergic reaction to compounds that are chemically or biologically similar to LC 6. Patient is taking a medication that may potentiate hemolysis 7. Unstable angina or myocardial infarction within the past 6 months 8. Prolonged QTc interval, Fridericia formula (QTcF) (\> 450 msec for males or \> 460 msec for females) 9. Psychiatric illness or social situation that could limit compliance with study requirements 10. Pregnant or breastfeeding
Contact & Investigator
Matthias Holdhoff, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05768919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05768919 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05768919 currently recruiting?
Yes, NCT05768919 is actively recruiting participants. Contact the research team at Msheeh13@jh.edu for enrollment information.
Where is the NCT05768919 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States.
Who is sponsoring the NCT05768919 clinical trial?
NCT05768919 is sponsored by SignPath Pharma, Inc.. The principal investigator is Matthias Holdhoff, MD at Johns Hopkins University. The trial plans to enroll 30 participants.
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