Health Trials

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

ConditionsAstrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-MutantRecurrent Adult Diffuse Midline Glioma, H3 K27-MutantRecurrent Astrocytoma, IDH-MutantRecurrent Astrocytoma, IDH-Mutant, Grade 3Recurrent Astrocytoma, IDH-Mutant, Grade 4Recurrent Glioblastoma, IDH-Wildtype
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Intensity-Modulated Radiation Therapy
  • Magnetic Resonance Imaging
  • Triapine

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

43
California
City of Hope Comprehensive Cancer Center91010, Duarte United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care92612, Irvine United States
UC San Diego Moores Cancer Center92093, La Jolla United States
UC Irvine Health/Chao Family Comprehensive Cancer Center92868, Orange United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov