AZD1390 + Radiation Therapy for Brain Cancer

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Oncology Group

Must not be taking: Investigational drugs, Anti-cancer agents, Anti-GVHD agents, Strong CYP3A4 inhibitors

Disqualifiers: Pregnancy, Uncontrolled infection, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and/or effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.

Research Team

Erin K Barr

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Eligibility Criteria

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

I have a specific type of brain tumor and am eligible for a certain radiation therapy.

I am between 12 months and 18 years old and interested in the dose escalation phase.

My diagnosis is a specific brain tumor located in the pons without needing a tissue sample.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-Radiation

Participants receive AZD1390 orally once within 5 days prior to radiation therapy

1 week

Radiation and Treatment

Participants receive AZD1390 orally once daily, 5 days per week, and radiation therapy on the same days for approximately 6 weeks

6 weeks

5 visits per week (in-person)

Post-Radiation Treatment

Participants receive AZD1390 on days 1-14 after radiation in the absence of disease progression or unacceptable toxicity

2 weeks

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

Up to 5 years

Regular follow-up visits

Treatment Details

Interventions

• AZD1390
• Radiation Therapy

Trial Overview The trial tests the safety, tolerability, and effectiveness of AZD1390 (a kinase inhibitor that blocks cancer cell multiplication) when given with radiation therapy. It aims to find the best dose of AZD1390 for treating certain types of aggressive brain tumors in children and young adults.

Participant Groups

Group I: Treatment (AZD1390 and radiation therapy) Experimental Treatment 5 Interventions

Patients receive AZD1390 PO once within 5 days prior to radiation therapy. Patients then receive AZD1390 PO QD, 5 days per week, Monday through Friday, and also receive radiation therapy on the same days for approximately 6 weeks. Patients then receive AZD1390 on days 1-14 after radiation in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection and may optionally undergo cerebrospinal fluid collection throughout the study.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+