Actively Recruiting
Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
Led by M.D. Anderson Cancer Center · Updated on 2025-10-29
29
Participants Needed
1
Research Sites
379 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form or consent from legally authorized representative if cognitively impaired
- Age 18 years or older
- Histologically confirmed WHO grade 4 glioma (glioblastoma) or gliosarcoma, IDH wild-type
- Karnofsky Performance Status (KPS) of 60 or higher or ECOG performance status 2 or less
- Brain MRI within 14 days before enrollment with stable or tapering steroid dose for at least 3 days
- Adequate organ function and labs within 14 days before study start
- Female participants of childbearing potential with negative pregnancy test and willing to use two birth control methods or be surgically sterile
- Male participants agreeing to use contraception during the study
- Newly diagnosed patients with documented MGMT unmethylated status and surgery or biopsy without further cancer treatments
- Recurrent glioblastoma patients with resectable disease, eligible for re-radiation, at least 6 months since last radiation, no prior re-radiation except stereotactic radiosurgery
You will not qualify if you...
- Prior interstitial brachytherapy or implanted chemotherapy
- Active treatment with tumor treating field devices during radiation (allowed during adjuvant temozolomide)
- Serious medical conditions interfering with study adherence
- Other malignancies within 2 years except low-risk, treated or surveilled cancers
- Disease in posterior fossa, gliomatosis cerebri, leptomeningeal or extracranial disease (except contiguous satellite lesions within radiation port)
- Conditions or therapies interfering with participation or safety
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnancy, breastfeeding, or planning conception during study
- Contraindication to MRI
- Inability to comply with study and follow-up
- Serious infection signs or recent IV antibiotics
- Recent live attenuated vaccine within 4 weeks before study or planned during study
- History of long QT syndrome
- Other conditions contraindicating Peposertib or increasing treatment risks
- Need for major surgery during study (except planned neuro-surgery in Stage II)
- Increased risk for radiation toxicity due to collagen vascular disease or inherited radiation sensitivity
- Difficulty swallowing or gastrointestinal disease affecting drug absorption
- Concomitant chemotherapy, immunotherapy, or radiotherapy outside study protocol
- For newly diagnosed, history of MGMT methylated status
- For recurrent, prior scalp or surgical wound infection or wound dehiscence
- Prior bevacizumab exposure except under defined conditions in Stage II
- Use of drugs affecting Peposertib metabolism or absorption as specified in protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nazanin Majd, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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