Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410248
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-06
Brief Title:
Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide TMZ for Patients With Recurrent Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cells DNA and may kill tumor cells and slow down or stop tumor growth Giving triapine in combination with temozolomide may be safe tolerable andor effective in treating patients with recurrent glioblastoma
Detailed Description:
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 Response Assessment in Neuro-Oncology RANO 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 potential interaction of drug absorption when administrating oral triapine and temozolomide together by measuring plasma levels triapine and temozolomide post administration
III To evaluate oral triapine plasma pharmacokinetics and corresponding methemoglobin level by venous blood gas proportion
IV To evaluate the quality of life per Functional Assessment of Cancer Therapy-Brain FACT-Br for patients treated with triapine and temozolomide
OUTLINE This is a dose-escalation study of triapine in combination with temozolomide Patients with recurrent glioblastoma not planning to undergo surgery are assigned to group 1 or group 2 Patients with recurrent glioblastoma planning to undergo surgery are assigned to group 3
GROUPS 1 AND 2 Patients receive temozolomide orally PO once daily QD and triapine PO QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI at screening and on study and undergo collection of blood samples on study
GROUP 3 Patients receive triapine PO QD for 5 days prior to surgical resection After surgical resection patients receive temozolomide PO QD and triapine PO QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo MRI at screening and on study and undergo collection of blood samples on study
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 24 months
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 Response Assessment in Neuro-Oncology RANO 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 potential interaction of drug absorption when administrating oral triapine and temozolomide together by measuring plasma levels triapine and temozolomide post administration
III To evaluate oral triapine plasma pharmacokinetics and corresponding methemoglobin level by venous blood gas proportion
IV To evaluate the quality of life per Functional Assessment of Cancer Therapy-Brain FACT-Br for patients treated with triapine and temozolomide
OUTLINE This is a dose-escalation study of triapine in combination with temozolomide Patients with recurrent glioblastoma not planning to undergo surgery are assigned to group 1 or group 2 Patients with recurrent glioblastoma planning to undergo surgery are assigned to group 3
GROUPS 1 AND 2 Patients receive temozolomide orally PO once daily QD and triapine PO QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI at screening and on study and undergo collection of blood samples on study
GROUP 3 Patients receive triapine PO QD for 5 days prior to surgical resection After surgical resection patients receive temozolomide PO QD and triapine PO QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo MRI at screening and on study and undergo collection of blood samples on study
After completion of study treatment patients are followed up at 30 days and then every 3 months for up to 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02351 | REGISTRY | None | None |
| STU00220426 | None | None | None |
| NU 23C05 | OTHER | None | None |
| P30CA060553 | NIH | Northwestern University | httpsreporternihgovquickSearchP30CA060553 |