Northwestern University
This phase I trial tests the safety, side effects, and best dose of triapine in combination with temozolomide in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Triapine inhibits an enzyme responsible for producing molecules required for the production of deoxyribonucleic acid (DNA), which may inhibit tumor cell growth. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Giving triapine in combination with temozolomide may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma.
PRIMARY OBJECTIVE: I. To evaluate the recommended phase 2 dose (RP2D) for triapine (3-AP) in combination with temozolomide (TMZ). SECONDARY OBJECTIVES: I. To evaluate the safety profile of triapine in combination with temozolomide (TMZ). II. To evaluate progression-free survival (PFS). III. To evaluate overall survival (OS). IV. To evaluate the overall response rate (ORR) per RANO 2.0 criteria. EXPLORATORY OBJECTIVES: I. To investigate the distribution of triapine within tumor and peritumoral areas post oral administration and correlation with serum levels. II. To investigate the potent…
Inclusion Criteria: * Patients must have histologically confirmed World Health Organization (WHO) grade 2-4 glioma, isocitrate dehydrogenase (IDH) wild type (WT) (by immunohistochemistry \[IHC\] R132H negative \[neg\] or sequencing). Astrocytoma with molecular features of glioblastoma (GBM). Confirmed diagnosis via molecular testing * Patients must have an established diagnosis of recurrent glioblastoma and: * Group 1 and 2: recurrent glioblastoma * Group 3: Surgically amenable recurrent glioblastoma * Patients must have stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg d…
Undergo collection of blood samples
Undergo MRI
Ancillary studies
Undergo surgical resection
Given PO
Given PO
Arctuva estimate
Verify or correct the compensation shown for this listing.