24 Participants Needed

PCI-24781 + Temozolomide for Recurrent Brain Cancer

MS
MK
Overseen ByMichaela K Savine, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including some antiepileptic drugs and specific medications like amiodarone, clarithromycin, and methadone, among others. If you are on these medications, you must discontinue or switch them before enrolling in the study.

Is the combination of PCI-24781 and Temozolomide safe for humans?

Temozolomide has been shown to have mild to moderate side effects like fatigue, nausea, and low blood cell counts, with severe effects being rare. Safety data for PCI-24781 specifically is not provided, but Temozolomide's safety profile is generally acceptable in humans.12345

What makes the drug Temozolomide unique for treating recurrent brain cancer?

Temozolomide is unique because it is an alkylating agent that works by adding a chemical group to the DNA of cancer cells, which can help stop their growth. It has shown effectiveness in treating various types of brain tumors, including gliomas and pituitary carcinomas, and is often used when other treatments have failed.16789

What data supports the effectiveness of the drug temozolomide for recurrent brain cancer?

Temozolomide has shown effectiveness in treating various types of brain tumors, including glioblastoma multiforme and anaplastic astrocytoma, and is being studied for other brain cancers. It is known for its ability to treat malignant gliomas and has been used successfully in combination with other treatments.18101112

Who Is on the Research Team?

NA

Nicole A Shonka, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults over 19 with recurrent high-grade glioma who've had prior radiation and temozolomide treatment. They must have good liver, kidney, and bone marrow function, not be pregnant or nursing, and agree to use birth control. Excluded are those with certain heart conditions, other active cancers (except some skin/prostate), specific infections or systemic illnesses that could affect safety.

Inclusion Criteria

I have recovered from side effects of previous cancer treatments.
I've had radiation and temozolomide treatment for my cancer.
I am 19 years old or older.
See 9 more

Exclusion Criteria

Baseline ECG showing QTc interval prolongation
I have recently used specific medications or therapies.
Lactating or pregnant
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PCI-24781/Abexinostat and metronomic temozolomide in 28-day cycles until disease progression or intolerance

Up to 25 months
Regular visits every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Extension

Participants with stable or responsive disease may continue therapy until intolerance or progressive disease

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • PCI 24781
  • Temozolomide
Trial Overview The study tests the combination of a drug called PCI-24781 with low-dose Temozolomide in patients whose brain cancer has returned. It aims to find the safest dose of this combo and assess its side effects in treating high-grade gliomas like astrocytoma or glioblastoma.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment2 Interventions

Temozolomide is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Temodal for:
🇺🇸
Approved in United States as Temodar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Xynomic Pharmaceuticals, Inc.

Industry Sponsor

Trials
11
Recruited
1,200+

Published Research Related to This Trial

In a phase II trial involving 46 patients with progressive low-grade glioma, Temozolomide (Temodar) demonstrated a 61% objective response rate, with 24% achieving complete response and 37% achieving partial response.
The treatment showed promising safety, with limited toxicity observed; however, one patient experienced severe complications, highlighting the need for careful monitoring during treatment.
Phase II trial of temozolomide in patients with progressive low-grade glioma.Quinn, JA., Reardon, DA., Friedman, AH., et al.[2022]
In a study involving 831 patients across 21 French hospitals, temozolomide (TMZ) prescriptions were found to conform to the French summary of product characteristics (SPC) in 51.9% of cases, indicating a moderate level of adherence to official guidelines.
The study revealed high conformity (91.5%) to the prescription guidebook, with specific adherence rates of 62% for newly diagnosed glioblastoma patients receiving combined treatment with radiotherapy, 72% for maintenance therapy, and 66% for patients with progressive disease, highlighting the overall compliance in clinical practice.
A multicenter prospective observational study of the conformity of temozolomide prescriptions in France.Tilleul, P., Brignone, M., Hassani, Y., et al.[2018]
In a phase II trial involving 38 patients with recurrent oligodendroglial tumors, temozolomide (TMZ) demonstrated a high response rate, with 52.6% of patients showing a complete or partial response, indicating its efficacy as a first-line chemotherapy.
TMZ was generally well tolerated, with hematologic side effects being the most common, and only one patient discontinuing treatment due to toxicity, suggesting a favorable safety profile for chemotherapy-naive patients.
Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971.van den Bent, MJ., Taphoorn, MJ., Brandes, AA., et al.[2022]

Citations

Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]
A multicenter prospective observational study of the conformity of temozolomide prescriptions in France. [2018]
Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. [2022]
Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme. [2018]
Future directions for temozolomide therapy. [2019]
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]
Role of temozolomide in pediatric brain tumors. [2022]
Temozolomide for the treatment of recurrent supratentorial glioma: results of a compassionate use program in Belgium. [2022]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Temozolomide-induced shrinkage of a pituitary carcinoma causing Cushing's disease--report of a case and literature review. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Temozolomide as second-line chemotherapy for relapsed gliomas. [2019]
Biochemical changes associated with a multidrug-resistant phenotype of a human glioma cell line with temozolomide-acquired resistance. [2022]
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