Triapine + Radiation Therapy for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Methemoglobinemia-inducing drugs

Disqualifiers: G6PD deficiency, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma or astrocytoma.

Who Is on the Research Team?

Stephanie M Yoon

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for patients with recurrent glioblastoma or astrocytoma who have previously undergone standard radiation therapy. Eligible tumors must be no larger than 6 cm in diameter, and there should be a minimum of a 6-month break since the last radiation dose. Patients with new tumors outside the original treatment field and confirmed tumor histology are included.

Inclusion Criteria

My brain tumor is IDH-wildtype, grade 2-4.

My tumor is 6 cm or smaller.

My scans show my cancer is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo intensity-modulated radiation therapy (IMRT) once daily 5 days per week for 2 weeks and receive triapine orally 2 hours prior to IMRT on each radiation treatment day

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at 2 weeks after radiation therapy, then every 3 months for up to 2 years

Up to 2 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triapine

Trial Overview The trial is testing Triapine combined with radiation therapy to determine safety, side effects, and optimal dosage. The goal is to see if this combination can effectively stop tumor growth by inhibiting certain enzymes needed for cell proliferation in patients with recurrent brain cancers.

How Is the Trial Designed?

Group I: Treatment (IMRT, triapine) Experimental Treatment 5 Interventions

Patients undergo IMRT QD 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine PO 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study as well as blood sample collection during screening and on study. Patients may undergo CSF sample collection during screening.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+