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Liposomal Curcumin + RT/TMZ for Brain Tumor
Phase 1 & 2
Recruiting
Led By Matthias Holdhoff, MD, PhD
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 up to 34 weeks
Awards & highlights
Study Summary
This trial tests if a supplement called Liposomal Curcumin is safe & effective in treating High-Grade Gliomas when used with radiation & chemotherapy.
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.Check my eligibility
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.See study design
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 up to 34 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of treatment for each patient up to 34 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of observed Dose Limiting Toxicity (DLTs)
Secondary outcome measures
Overall Survival (OS)
Progression free survival (PFS)
The incidence of Adverse Events
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tolerability, Safety, and Efficacy of LC in Combination with RT and TMZExperimental Treatment3 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.
Find a Location
Who is running the clinical trial?
Avance ClinicalUNKNOWN
3 Previous Clinical Trials
167 Total Patients Enrolled
SignPath Pharma, Inc.Lead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
Avance Clinical Pty Ltd.Industry Sponsor
13 Previous Clinical Trials
2,620 Total Patients Enrolled
1 Trials studying Glioblastoma
48 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have side effects from cancer treatment, except for hair loss.I am 18 years old or older.I have a high-grade glioma brain tumor suitable for radiation and chemotherapy treatment.I have not had treatment for any cancer other than skin cancer in the last 2 years.I am currently on antibiotics for an infection.I am on medication that could increase the risk of red blood cells breaking down.I have not had a heart attack or unstable chest pain in the last 6 months.I am scheduled for 6 weeks of treatment with TMZ and radiation.I can care for myself but may need occasional help.
Research Study Groups:
This trial has the following groups:- Group 1: Tolerability, Safety, and Efficacy of LC in Combination with RT and TMZ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spots available in this experiment?
"Affirmative. The information available on clinicaltrials.gov indicates that the recruitment for this medical trial, which was originally uploaded to their database on March 1st 2023, is ongoing. An estimated 30 participants need to be sourced from a single site."
Answered by AI
How many individuals are being invited to participate in this clinical trial?
"Correct. The clinicaltrials.gov database ascertains that this investigation is actively recruiting volunteers, having been initially posted on March 1st 2023 and revised shortly afterwards on the 2nd of the same month. 30 participants are needed from a single centre for enrolment in this trial."
Answered by AI
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