Study on Liposomal Curcumin with Radiation and Chemotherapy for Newly Diagnosed High-Grade Brain Tumors

Sponsor: SignPath Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05768919

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment using Liposomal Curcumin combined with radiation and chemotherapy in patients with newly diagnosed high-grade brain tumors.

Patient Parameters

Program Overview

The aim of this study is to see if Liposomal Curcumin, when used with radiation therapy and the chemotherapy drug Temozolomide, is safe and effective for patients with newly diagnosed high-grade brain tumors. Researchers want to find the best dose and see how well patients tolerate this combination treatment.

Description

This study is in its early stages (Phase 1/2) and is being conducted at a single location. It is open-label, meaning both the researchers and participants know what treatment is being given. The study will test different doses of Liposomal Curcumin to find the highest dose that patients can tolerate when combined with radiation and Temozolomide.

The main goals are to determine the safest dose of Liposomal Curcumin and to see how well patients tolerate it when given with radiation and Temozolomide. Researchers will also look at how many patients can complete most of the planned treatment and how the treatment affects survival and disease progression.

About 50 patients will be screened to find up to 30 participants for the study. Each participant will receive treatment for up to 34 weeks, starting with the first infusion and continuing through six cycles of Temozolomide, if tolerated.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of high-grade brain tumor (WHO grade III or IV), including specific types like glioblastoma and astrocytoma.
  • Planning to receive standard treatment with Temozolomide and radiation for 6 weeks.
  • Have a Karnofsky Performance Scale score of 60% or higher, indicating the ability to care for oneself with some assistance.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • Patients with HIV can participate if their viral load is undetectable with treatment.
  • Women of childbearing potential must agree to use effective birth control during the study.
  • Men must agree to use effective birth control during the study and for 4 months after completing Liposomal Curcumin treatment.

Exclusion Criteria

  • Have another untreated or active cancer, except for certain skin cancers, within the past 2 years.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Are taking any other experimental drugs.
  • Have an active infection requiring antibiotics.
  • Have a history of allergic reactions to similar compounds as Liposomal Curcumin.
  • Are taking medications that may cause red blood cell breakdown.
  • Have had unstable chest pain or a heart attack in the past 6 months.
  • Have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
  • Have a psychiatric condition or social situation that may affect study participation.
  • Are pregnant or breastfeeding.

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