RecruitingPhase 1Phase 2NCT05768919

Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas

Phase I/II Study of the Tolerability, Safety, and Efficacy of Liposomal Curcumin in Combination With Radiation and Temozolomide in Patients With Newly Diagnosed High-Grade Gliomas

Sponsor

SignPath Pharma, Inc.

Enrollment

30 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing liposomal curcumin (a plant-based compound delivered in a special fat coating for better absorption) combined with standard chemotherapy and radiation in patients newly diagnosed with high-grade gliomas — fast-growing brain tumors. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a high-grade brain tumor (WHO grade III or IV, including glioblastoma, astrocytoma, gliosarcoma, or H3K27M mutant diffuse midline glioma) - Your treatment plan includes standard chemoradiation (radiation + temozolomide) - Patients with either methylated or unmethylated MGMT promoter are eligible **You may NOT be eligible if...** - You have previously been treated with radiation or chemotherapy for a brain tumor - You have medical conditions that would prevent participation in standard chemoradiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreatment Period 1

Agent: LipoCurc Premedication/Precautions: Dexamethasone 4mg IV, Diphenhydramine 25 mg IV - Dose: per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Weeks 1,2, 3,4,5,6 Cycle length: 6 weeks Agent: TMZ Premedications/Precautions No food 2 hr before and after dosing Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener PRN. Dose: 75 mg/m2 Route: Oral Schedule: Daily during term of RT Cycle Length: 6 weeks Agent: Radiotherapy Premedications/Precautions: n/a Dose: 2 Gy Route: External beam therapy Schedule: Monday-Friday Cycle Length 6 weeks

DRUGTreatment Period 2

DRUGTreatment Period 3

Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Adjuvant Cycles 11-34 Weeks 1, 2, 3, 4 of each cycle Cycle Length: 4 weeks Agent: TMZ Premedication/Precautions: No food 2 hr before and after dosing. Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener prn Dose: 150-200 mg/m2 (Cycles 1-6) Route: Oral Schedule: Daily Cycle Length: 4 weeks

DRUGTreatment Period 4a