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Liposomal Curcumin + RT/TMZ for Brain Tumor

Phase 1 & 2

Recruiting

Led By Matthias Holdhoff, MD

Research Sponsored by SignPath Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the duration of treatment for each patient, minimum of 34 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment combining a special form of curcumin with radiation and chemotherapy for patients with aggressive brain tumors. The goal is to improve curcumin absorption and enhance the effects of standard treatments.

Who is the study for?

Adults over 18 with newly diagnosed High-Grade Gliomas, including GBM and other types, suitable for RT/TMZ treatment. Must have good organ function, not be pregnant or breastfeeding, no recent heart issues or active infections requiring antibiotics. HIV-positive patients can join if undetectable viral load. Participants must agree to use contraception.

What is being tested?

The trial is testing the safety and effectiveness of Liposomal Curcumin (LC) when used alongside standard radiotherapy (RT) and Temozolomide (TMZ). The study will observe how well patients tolerate this combination therapy during different treatment periods: adjuvant, post-CRT, and concurrent CRT.

What are the potential side effects?

Potential side effects may include reactions similar to those from compounds like LC such as allergic responses. Other risks could involve typical chemotherapy-related side effects like fatigue, digestive problems, blood disorders but specific side effect profiles of LC will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the duration of treatment for each patient, minimum of 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the duration of treatment for each patient, minimum of 34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of treatment for each patient, minimum of 34 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of observed Dose Limiting Toxicity (DLTs)

Secondary study objectives

Overall Survival (OS)

Progression free survival (PFS)

The incidence of Adverse Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tolerability, Safety, and Efficacy of LC in Combination with RT and TMZExperimental Treatment4 Interventions

Define the MTD/recommended Phase 2 dose (RP2D) of LC, administered IV weekly in combination with standard CRT (60 Gy in 30-33 fractions M-F, and daily oral TMZ 75 mg/m2), in patients with high grade malignant gliomas. This study seeks the MTD/RP2D of LC when added to TMZ during concurrent RT and adjuvant TMZ after RT. The study will evaluate escalating doses of LC delivered by IV infusion weekly as a gravity infusion (without infusion pump). Within each cohort, the dose will remain the same. In the first cohort, dosing will begin at Level 1 (300 mg/m2). The infusion of LC will begin at the start of CRT. Patients will be evaluable for the cohort if they have completed 80% of the planned doses of LC, 80% of RT and 60% of TMZ within the first 10 weeks of treatment. Patients who experience a dose-limiting toxicity (DLT) will be evaluable for the cohort if they have received at least 1 dose of LC.

Do I qualify?Apply below to find out