Actively Recruiting
Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
Led by SignPath Pharma, Inc. · Updated on 2024-11-29
30
Participants Needed
2
Research Sites
217 weeks
Total Duration
On this page
Sponsors
S
SignPath Pharma, Inc.
Lead Sponsor
A
Avance Clinical Pty Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed high-grade glioma (WHO grade III or IV, including glioblastoma, astrocytoma, gliosarcoma, or H3K27M mutant diffuse midline glioma)
- Eligible regardless of MGMT promoter methylation or IDH mutation status if planned for combined radiotherapy and Temozolomide treatment
- Karnofsky Performance Scale score of 70% or higher
- Adequate organ and marrow function including hemoglobin > 9 g/dL, ANC ≥ 1500/μL, platelet count ≥ 100,000/μL, total bilirubin ≤ 1.5 times institutional upper limit, AST and ALT ≤ 3 times institutional upper limit, and eGFR ≥ 60 mL/min/1.73 m2 (or ≥ 30 mL/min/1.73 m2 with supporting data)
- Patients with HIV on effective antiretroviral therapy with undetectable viral load within 6 months
- Women of childbearing potential must agree to use adequate contraception during the study
- Men must agree to use adequate contraception during the study and for 4 months after completing Liposomal Curcumin therapy
You will not qualify if you...
- Any untreated, actively treated, or recently treated (within 2 years) cancer except squamous or basal cell skin cancer
- Unresolved side effects from prior anticancer therapy greater than grade 1, except alopecia
- Receiving any other investigational treatment
- Active infection requiring systemic antibiotics
- History of allergic reaction to compounds similar to Liposomal Curcumin
- Taking medications that may increase risk of hemolysis
- Unstable angina or heart attack within the past 6 months
- Prolonged QTc interval over 450 msec in males or 460 msec in females
- Psychiatric or social conditions that could limit study compliance
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Johns Hopkins University/Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
M
Michaella Lacoboni, RN, BSN
CONTACT
M
Michelle Comas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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