RecruitingAstrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-MutantRecurrent Adult Diffuse Midline Glioma, H3 K27-Mutant

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:
✓ GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)
✓ Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)
✓ Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.
✓ Tumors ≤ 6 cm in maximal diameter.
✓ Patients who had recent resection for recurrent tumor must have measurable disease.
✓ Patients must have at least a 6-month break from last dose of radiation therapy.
✓ Re-irradiation within 6 months may increase risk for radiation necrosis/edema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect.

You may not qualify if…

✕ Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
✕ Patients who are receiving any other investigational agents.
✕ Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \[primaquine, chloroquine\], cyclophosphamide, and ifosfamide).
✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.
✕ Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.
✕ Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
✕ Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.