RecruitingPhase 1NCT04555577

Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma

Phase I Trial of DNA-PK Inhibitor (M3814) in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated Glioblastoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

29 participants

Start Date

Sep 20, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial investigates the side effects and best dose of Peposertib, and to see how well it works in combination with radiation therapy in treating patients with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Peposertib may further stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Peposertib with radiation therapy may work better than radiation therapy alone in treating patients with glioblastoma or gliosarcoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called peposertib combined with radiation therapy, followed by a chemotherapy drug (temozolomide), for patients newly diagnosed with glioblastoma — the most aggressive form of brain cancer — in cases where the tumor lacks a specific repair gene (MGMT unmethylated). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with glioblastoma (grade 4 brain tumor) or gliosarcoma confirmed by biopsy - You have not received prior treatment for this brain tumor - You are in reasonably good functional health - Your organs are functioning adequately - You have had a recent brain MRI (within 14 days of starting) **You may NOT be eligible if...** - Your tumor has IDH mutations (a different subtype of brain tumor) - You have severe organ dysfunction unrelated to your brain tumor - You are pregnant or breastfeeding - You cannot tolerate radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPeposertib

Given PO

RADIATIONRadiation Therapy

Undergo radiation therapy

PROCEDUREResection

Undergo surgical resection

DRUGTemozolomide

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04555577


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