At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed WHO grade 4 glioma (GBM) or gliosarcoma, IDH wild-type, per WHO 2021 classification
- ✓Age 18 years or older
- ✓KPS ≥60 or ECOG ≤2
- ✓Baseline MRI of brain obtained no more than 14 days prior to study enrollment on stable or tapering dose of steroids for at least 3 days
- ✕Prior interstitial brachytherapy or implanted chemotherapy
- ✕Active treatment with tumor treating field devices (Optune) during radiation; concurrent use during adjuvant temozolomide allowed
- ✕Serious medical condition interfering with adherence to study procedures
- ✕Malignancies other than GBM within 2 years (with exceptions for negligible-risk or curative treatments)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Trial of DNA-PK Inhibitor (PEPOSERTIB ) in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated and Recurrent Glioblastoma
In Brief
A Phase 1 clinical trial evaluating Peposertib, Radiation Therapy, and 2 other interventions for Glioblastoma and Gliosarcoma. Active but no longer recruiting, targeting 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
CONCURRENT: Patients undergo standard of care radiation therapy daily (Monday-Friday) for 30 fractions. Patients also receive Peposertib PO on each day of radiation therapy and given 1-2 hours before each treatment fraction. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. ADJUVANT: Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
CONCURRENT: Patients receive Peposertib and undergo standard of care radiation therapy as in Stage I. Within 1-14 days after the completion of radiation therapy, patients undergo surgical resection. ADJUVANT: Patients receive temozolomide as in Stage I.
Interventions
Given PO
Undergo radiation therapy
Undergo surgical resection
Given PO