AZD1390 + Radiation Therapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best dose and assess the safety of a new drug, AZD1390, when combined with radiation therapy to treat certain types of brain cancer in children and young adults. AZD1390 stops cancer cells from multiplying, while radiation therapy uses high-energy rays to kill cancer cells. Together, they may effectively treat high-grade glioma and diffuse midline glioma, including diffuse intrinsic pontine glioma. The trial seeks patients newly diagnosed with these brain cancers who have not yet received radiation or other cancer treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications to join the trial. Specifically, you cannot take other investigational drugs, anti-cancer agents (except corticosteroids), or strong inhibitors or inducers of the CYP3A4/5 enzyme. If you are on these, you should stop them at least 2 weeks before starting the trial (3 weeks for St John's Wort).
Is there any evidence suggesting that AZD1390 and radiation therapy are likely to be safe for humans?
Research has shown that AZD1390, when combined with radiation therapy, is generally safe for patients with brain tumors like glioblastoma. While side effects occur, they are usually mild and manageable. In studies involving AZD1390, patients have undergone treatment without major issues. This drug targets cancer cells to inhibit their growth. The current trial aims to determine the optimal dose and ensure safety for children with high-grade gliomas. Although this is an early-stage trial, existing evidence suggests that combining AZD1390 with radiation therapy is relatively safe in similar adult groups.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for brain cancer, which often involve traditional chemotherapy and radiation, AZD1390 is unique because it is a targeted therapy that enhances the effects of radiation. AZD1390 works by inhibiting a protein involved in DNA repair, which potentially makes cancer cells more vulnerable to radiation. Researchers are excited about AZD1390 because this targeted approach could lead to more effective treatment outcomes with potentially fewer side effects compared to conventional options. This combination of precision targeting and radiation might offer new hope for patients by improving the effectiveness of the treatment regimen.
What evidence suggests that AZD1390 combined with radiation therapy might be an effective treatment for brain cancer?
Research has shown that AZD1390, when combined with radiation therapy, could be promising for treating brain cancers like glioblastoma. In previous studies, patients who took AZD1390 with radiation experienced manageable side effects and showed positive early results. Initial data suggests that AZD1390 might enhance the effectiveness of radiation therapy by increasing cancer cells' sensitivity. Specifically, one study found that patients receiving this combination lived for a median of 12.7 months. These findings suggest that AZD1390 could be effective in treating aggressive brain tumors. Participants in this trial will receive the combination of AZD1390 and radiation therapy to further evaluate its effectiveness and safety.12567
Who Is on the Research Team?
Erin K Barr
Principal Investigator
Pediatric Early Phase Clinical Trial Network
Are You a Good Fit for This Trial?
This trial is for pediatric patients aged between 12 months and less than 22 years with newly diagnosed high-grade gliomas, including diffuse midline glioma or diffuse intrinsic pontine glioma. Eligible participants can have tumors in various brain regions but must be able to receive specific radiation therapy doses. Histologic confirmation of malignancy is required except for typical DIPG cases.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Radiation
Participants receive AZD1390 orally once within 5 days prior to radiation therapy
Radiation and Treatment
Participants receive AZD1390 orally once daily, 5 days per week, and radiation therapy on the same days for approximately 6 weeks
Post-Radiation Treatment
Participants receive AZD1390 on days 1-14 after radiation in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-ups at 30 days, every 8 weeks until progression or 2 years after the last dose of AZD1390, and at 22 and 44 weeks after completion of radiation therapy
What Are the Treatments Tested in This Trial?
Interventions
- AZD1390
- Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor