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Compensation: Varies

Number of Visits: 1

Duration: 34 weeks

30 Participants Needed

Liposomal Curcumin + RT/TMZ for Brain Tumor

Recruiting at 2 trial locations

Overseen ByMichelle Comas

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SignPath Pharma, Inc.

Must be taking: Temozolomide

Must not be taking: Investigational agents

Disqualifiers: Concurrent cancer, Active infection, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with aggressive brain tumors known as High-Grade Gliomas. The researchers aim to determine if adding Liposomal Curcumin (a form of curcumin, a compound in turmeric) to the standard treatment of radiotherapy and Temozolomide (a chemotherapy drug) is safe and effective. Individuals diagnosed with these brain tumors and planning to start standard therapy with Temozolomide and radiotherapy might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking a medication that may increase the risk of hemolysis (breakdown of red blood cells), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Liposomal Curcumin (LC) is generally safe. Previous studies with both healthy individuals and cancer patients found that LC is usually well-tolerated. Even at doses up to 300 mg/m², side effects remained manageable.

Curcumin, the main ingredient in LC, may help treat brain tumors like glioblastoma, making it a promising addition to standard treatments such as radiotherapy (RT) and Temozolomide (TMZ).

So far, studies have not reported any serious side effects from using LC with these treatments, suggesting that LC might be safe for people with high-grade brain tumors.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about Liposomal Curcumin (LC) for brain tumors because it introduces a novel approach by combining a natural compound, curcumin, with advanced drug delivery technology. Unlike standard treatments like radiotherapy and temozolomide alone, LC utilizes liposomes to enhance the absorption and stability of curcumin, potentially boosting its effectiveness against high-grade gliomas. This delivery method allows for targeted treatment, which could improve tolerability and reduce side effects. Additionally, LC's potential to work synergistically with existing therapies could lead to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for high-grade gliomas?

Research has shown that curcumin, the main ingredient in Liposomal Curcumin (LC), can enhance the effects of chemotherapy and radiation. It also helps protect healthy tissue and may slow cancer spread. Studies with cancer patients have found that LC is safe and well-tolerated, even at higher doses. In this trial, participants will receive a combination of Temozolomide (TMZ) with radiotherapy (RT), which has shown promising results for aggressive brain tumors. Adding LC to this treatment regimen could potentially increase its effectiveness.² ³ ⁴ ⁶ ⁷

Who Is on the Research Team?

Matthias Holdhoff, MD

Principal Investigator

Johns Hopkins University

Peter Sordillo, MD, PhD

Principal Investigator

SignPath Pharma

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Adequate organ and marrow function defined as: Hgb > 9 g/dL, ANC ≥ 1500/µL, Platelet count ≥ 100,000/µL, Total bilirubin ≤ 1.5 * institutional ULN, AST and ALT ≤ 3 * institutional ULN, Creatinine ≤ 1.5 * institutional ULN OR Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 unless data exist supporting safe use at lower values of renal function, but eGFR must be ≥ 30 mL/min/1.73 m2, Patients with human immunodeficiency virus (HIV) who are on effective antiretroviral therapy are eligible if the viral load was assessed as undetectable within 6 months prior to baseline, Women: WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation, Men: must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of LC administration

I have a high-grade glioma brain tumor suitable for radiation and chemotherapy treatment.

I am scheduled for 6 weeks of treatment with TMZ and radiation.

See 1 more

Exclusion Criteria

I still have side effects from cancer treatment, except for hair loss.

Receiving any other investigational agent

I have not had treatment for any cancer other than skin cancer in the last 2 years.

See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Liposomal Curcumin (LC) in combination with radiotherapy (RT) and Temozolomide (TMZ) for a minimum of 34 weeks

34 weeks

Weekly visits for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival (OS) and progression-free survival (PFS)

Ongoing

Regular phone or clinic follow-up

Dose Escalation

Dose finding using a time-to-event Bayesian optimal interval (TITE-BOIN) rule-based schema to determine the maximum tolerated dose (MTD) of LC

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

Liposomal Curcumin
Radiotherapy
Temozolomide

Trial Overview 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.

How Is the Trial Designed?

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.

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in United States as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Canada as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

SignPath Pharma, Inc.

Lead Sponsor

Trials

Recruited

110+

Avance Clinical

Collaborator

Trials

Recruited

200+

Avance Clinical Pty Ltd.

Industry Sponsor

Trials

Recruited

3,700+

Published Research Related to This Trial

In a randomized trial involving 144 patients with anaplastic astrocytoma (AA) and glioblastoma (GBM), neoadjuvant temozolomide (NeoTMZ) did not show a survival advantage for the overall population or for GBM patients compared to radiotherapy alone.

However, patients with AA who received NeoTMZ had a significantly longer median survival of 95.1 months compared to 35.2 months for those receiving only radiotherapy, indicating a potential benefit of NeoTMZ specifically for AA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative neoadjuvant temozolomide before radiotherapy versus standard radiotherapy in patients 60 years or younger with anaplastic astrocytoma or glioblastoma: a randomized trial.Malmström, A., Poulsen, HS., Grønberg, BH., et al.[2018]

In a study of 27 patients with newly diagnosed high-grade gliomas, the combination of temozolomide (TMZ) and radiation therapy (RT) demonstrated promising efficacy, with a median overall survival of 19 months and a one-year survival rate of 81.2%.

The treatment was well tolerated with no drug toxicity-related mortality, indicating a favorable safety profile, especially in patients under 50 years old and those who had debulking surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcomes of concomitant radiation plus temozolomide followed by adjuvant temozolomide for newly diagnosed high grade gliomas: the preliminary results of single center prospective study.Shawky, H., Abo Hamar, AH., Galal, S., et al.[2020]

Temozolomide (TMZ) is an effective oral treatment for malignant gliomas, providing significant survival benefits while being generally well tolerated by patients.

While most side effects of TMZ are mild to moderate, there is a risk of severe hematologic adverse events, such as myelodysplastic syndrome and aplastic anemia, which have been documented in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide-related hematologic toxicity.Scaringi, C., De Sanctis, V., Minniti, G., et al.[2018]

Citations

1.clinicaltrials.govclinicaltrials.gov/study/NCT05768919

Study of Liposomal Curcumin in Combination With RT and ...The objective of this study is to assess the tolerability, safety, and efficacy of Liposomal Curcumin (LC) in combination with radiotherapy (RT) and ...

2.ncbi.nlm.nih.govncbi.nlm.nih.gov/books/NBK570704/

Therapeutic Potential of Curcumin for the Treatment of ... - NCBICurcumin has been shown to potentiate the effects of chemotherapy and radiation, decrease malignant spread, protect normal tissue from oxidative stress, and ...

3.trials.braintumor.orgtrials.braintumor.org/trials/NCT05768919

4.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC6132848/

A phase 1 dose-escalation study on the safety, tolerability ...This study was conducted to investigate the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer.

5.withpower.comwithpower.com/trial/liposomal-curcumin-rttmz-for-brain-tumor-a7475

Liposomal Curcumin + RT/TMZ for Brain TumorIn a study of 27 patients with newly diagnosed high-grade gliomas, the combination of temozolomide (TMZ) and radiation therapy (RT) demonstrated promising ...

6.firstwordpharma.comfirstwordpharma.com/story/5956697

SignPath Pharma Announces ASCO 2025 Abstract ...SignPath Pharma, developer of LipoCurc™, a liposomal curcumin formulation in clinical development for glioblastoma.

7.asco.orgasco.org/abstracts-presentations/ABSTRACT499172

Liposomal curcumin and standard radiation ...Previous trials in healthy volunteers and cancer patients demonstrated LC's safety, pharmacokinetics, and manageable adverse effects, with doses up to 300 mg/m² ...

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Liposomal Curcumin + RT/TMZ for Brain Tumor

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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