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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and CSF sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Triapine

    Drug

    Given PO

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (IMRT, triapine)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity

Will be graded in severity according to the Common Terminology Criteria for Adverse Events version 5.0. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized with descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient and frequency tables will be reviewed to determine toxicity patterns. Will employ the Backfill Bayesian Optimal Interval design to guide dose escalation and establish the maximal tolerated dose (MTD). The target toxicity rate for the MTD is = 0.25.

Time frame
Up to 28 days

Secondary outcomes

1

Response rate

Response rate will be categorized based on the Response Assessment in Neuro-Oncology criteria, in which tumor response is based on clinical history, physical exam, and imaging findings. The total number of patients in each response category divided by the total number of evaluable patients determines response rate. An evaluable patient is defined as an eligible patient who received at least one dose of triapine. The response rates will be calculated with corresponding 95% exact Clopper-Pearson confidence intervals.

Time frame
Up to 5 years
2

Plasma pharmacokinetic (PK) parameters

Triapine in plasma and peri-tumoral dialysate will be quantified using a validated liquid chromatography-tandem mass spectrometry assay. Plasma PK parameters will be derived and compared to historical controls. Dialysate concentrations will be calculated at multiple time points. Exploratorily, exposure-response relationships will be evaluated.

Time frame
Up to 2 weeks
3

Progression-free survival

Will be estimated using Kaplan Meier curves.

Time frame
From study enrollment to date of either disease progression or death, assessed up to 5 years
4

Overall survival

Will be estimated using Kaplan Meier curves.

Time frame
From study enrollment to date of death, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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