Neoplasms

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Glioblastoma

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Glioma

Neoplasms, Neuroepithelial

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Azeliragon to be administered once daily for several days before, during, and after radiation therapy.

Azeliragon

Stephen G Marcus, MD

Jenna Bourdeau

Paul Ferguson

Anais Vega

Mary Martin, RN

Prakash Chinnaiyan, MD

Jiayi Huang, M.D.

Tamika Wong

John Boockvar, MD

Oleta Korah, RN

Neurooncology CoordinationStaff

Jonathan Yang, MD

This is a phase 2 study to evaluate the safety and preliminary evidence of effectiveness of azeliragon, in combination with radiation therapy, as an initial treatment of a form of glioblastoma. Glioblastoma is a type of brain cancer that grows quickly and can invade and destroy healthy tissue. There's no cure for glioblastoma, which is also known as glioblastoma multiforme. Treatments, including surgery, radiation, and chemotherapy might slow cancer growth and reduce symptoms. New treatments of glioblastoma are needed.

The study to be conducted is a phase 2 study in newly diagnosed "unmethylated" glioblastoma.

As compared to "methylated" glioblastoma "unmethylated" glioblastoma carries a worse prognosis, as it is resistant to temozolomide, the most commonly prescribed chemotherapeutic treatment. Based upon pre-clinical evidence suggesting that azeliragon may enhance the effectiveness of radiation, as well as have a delaying effect on disease progression, this study will combine daily oral azeliragon with radiation treatment, followed by continued administration of azeliragon after completion of radiation therapy.

Azeliragon is administered once daily as an oral capsule. In previous studies in patients with Alzheimer's disease and in normal volunteers, azeliragon was well tolerated for up to 18 months.

Azeliragon in MGMT Unmethylated Glioblastoma

A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients With MGMT Unmethylated Glioblastoma

Progression-free survival (PFS) of newly diagnosed unmethylated GBM treated with the combination of RT and azeliragon.

Overall survival (OS) of newly diagnosed unmethylated GBM after RT and azeliragon

To evaluate overall response rate and duration of response as per RANO criteria

Change in requirement of dexamethasone after RT

Medpace, Inc.

Cantex Pharmaceuticals

Antineoplastic Agents

All Drugs and Chemicals

Alcohol Deterrents

Micronutrients

Anti-Infective Agents

Central Nervous System Depressants

Mineral

Temozolomide

Disulfiram

Copper

Antineoplastic Agents, Alkylating

Alkylating Agents

Trace Elements

Ethanol

Enzyme Inhibitors

Copper Supplement

Disulfiram (DSF; oral) / copper gluconate (Cu; oral) dosed at 125 mg / 2 mg, twice daily. Temozolomide will be administered following the standard Stupp protocol at a dose of 75 mg/m2 for 42 days with concurrent radiation therapy. Temozolomide maintenance dose will be 150 mg/m2 once daily on Days 1-5 of every 28-day cycle while DSF-Cu is continued twice daily, as tolerated, for the duration of the Temozolomide adjuvant treatment. Patients demonstrating continued benefit from the adjuvant temozolomide after 6 cycles can continue treatment to a maximum of 12 cycles

Copper gluconate is taken orally, twice daily

Copper gluconate

Asadullah Khan, MD

One of Disulfiram antitumor effects suggested in preclinical studies is MGMT (methyl-guanine-methyl-transferase) inhibition. Disulfiram MGMT inhibitory effect is enhanced by addition of Copper. This study evaluates the impact of Disulfiram (DSF) + Copper (Cu) combination when added to standard Temozolomide in the treatment of unmethylated Glioblastoma Multiforme (GBM) patients.

Glioblastoma is the most common malignant primary brain tumor and one of the most devastating cancers. The current standard of care for glioblastoma includes maximal safe resection followed by radiotherapy and temozolomide, which results in a median progression-free survival of less than 7 months, and median overall survival (OS) of less than 15 months. Moreover, patients with unmethylated glioblastoma respond poorly to this current standard treatment. This clinical trial evaluates the potential role of continuous, upfront use of Disulfiram in combination with Copper gluconate in enhancing temozolomide effect in the treatment of unmethylated Glioblastoma multiforme (GBM) patients.

Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme

A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients With Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme

To determine 6 month PFS of patients with unmethylated glioblastoma treated with DSF-Cu in combination with concurrent radiation and temozolomide. This was assessed by the number of participants who did not have disease progression and were alive at 6 months.

Overall Survival will be assessed as a number of participants alive at 1 and 2 years.

Edmonton Symptom Assessment System - Revised (ESAS-r) questionnaire

Aurora Health Care

13 participants started the treatment and the only ones assessed for adverse events. All participants were included in all cause mortality.

Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme

Open Label

Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme.

DSF will be given at 125 mg (half of a 250 mg capsule) two times daily with meals. Cu gluconate will be taken with each dose of DSF at a dose of 2 mg (one capsule/tablet). The DSF total daily dose will be 250 mg per day, as lower dose may be associated with a higher MGMT inhibitory effect.

15 subjects consented, Age data was not collected for 2 participants - 1 subject was a screen fail and 1 subject withdrew before any planned intervention.

Age, Categorical

Both men and women and members of all races and ethnic groups are eligible for this trial

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

15 subjects consented, 1 subject was a screen fail and 1 subject withdrew before any planned intervention.

Manager of Oncology research

6 Months Progression Free Survival (PFS)

1 Year

2 Years

2 participants are not included here because 1 was a screen fail and 1 withdrew before starting treatment.

Overall Survival

Disease progression or required dose modification from all participants took them all off the study. No data was collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Azeliragon in MGMT Unmethylated Glioblastoma	NCT05986851	Glioblastoma	Azeliragon	18 Years -	Cantex Pharmaceuticals
Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme	NCT03363659	Glioblastoma Glioblastoma Mu...	Disulfiram Copper gluconat... Temozolomide	18 Years -	Aurora Health Care

Spots Global Cancer Trial Database for unmethylated

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