ATM-Inhibitor + Radiation for Brain Tumor
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking enzyme-inducing anticonvulsants at least two weeks before enrolling. If you are taking more than 8 mg of dexamethasone per day, you will also need to adjust your dosage before joining the trial.
What data supports the effectiveness of the drug WSD0628, an ATM kinase inhibitor, when combined with radiation for treating brain tumors?
Research on similar ATM inhibitors, like AZD1390 and AZ32, shows they can make brain tumors more sensitive to radiation, leading to better tumor control and increased survival in animal models. These inhibitors work by blocking the tumor's ability to repair DNA damage caused by radiation, making the treatment more effective.12345
Is the ATM-Inhibitor + Radiation treatment generally safe for humans?
The research does not provide specific safety data for humans, but it shows that ATM inhibitors like AZD1390 and AZ32 have been tested in animal models, where they were effective in enhancing the effects of radiation on tumors. These studies are a step towards understanding their safety and effectiveness in humans.12456
How is the drug WSD0628 different from other brain tumor treatments?
WSD0628 is unique because it is an ATM kinase inhibitor that enhances the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. Unlike many treatments, it is designed to penetrate the blood-brain barrier, which is a common challenge in treating brain tumors, allowing it to target brain tumors more effectively.12347
What is the purpose of this trial?
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
Research Team
William G. Breen, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
Adults over 18 with recurrent brain tumors, specifically Glioblastoma or Grade 3/4 astrocytoma, who've had prior radiation and chemo. They must be able to take light-protective measures, provide tissue samples for research, have a life expectancy of at least 3 months, and meet certain health criteria like adequate blood counts and liver function. Pregnant or nursing individuals and those not using contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive WSD0628 treatment starting the day before radiation therapy, which is given for 10 consecutive business days. This phase aims to determine the maximum tolerated dose using the Bayesian Optimal Interval design.
Dose Expansion
Participants receive WSD0628 treatment at the recommended Phase 2 dose, starting the day before radiation therapy, which is given for 10 consecutive business days.
Tumor Penetrance
One treatment of WSD0628 is given prior to radiation and surgical resection is performed on the same day to evaluate tumor penetrance.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of anti-tumor activity and adverse events.
Treatment Details
Interventions
- WSD0628
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Food and Drug Administration (FDA)
Collaborator
National Cancer Institute (NCI)
Collaborator