NCT02395692

Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma

Phase II Study of TRC102 in Combination With Temozolomide for Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well methoxyamine works when added to standard temozolomide in treating patients with glioblastoma that has come back. Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the efficacy of TRC102 (methoxyamine) and temozolomide, as measured by response rate, in bevacizumab naïve glioblastoma. (Arm I) II. To estimate the efficacy of TRC102 and temozolomide, as measured by response rate, in bevacizumab refractory glioblastoma. (Arm II) SECONDARY OBJECTIVES: I. Evaluate the toxicities of oral TRC102 and temozolomide in this patient population. II. Estimate the efficacy of TRC102 and temozolomide, as measured by progression-free survival, progression-free survival at 6 months and overall survival, in bevacizumab naïve glioblastoma. III. Estimate the efficacy of TRC102 and temozolomide, as measured by progression-free survival in bevacizumab refractory glioblastoma. TERTIARY OBJECTIVES: I. Assess the tissue correlates of N-methylpurine-deoxyribonucleic acid (DNA) glycosylase (MPG), topoisomerase II-alpha (topo II a), and O-6-methylguanine-DNA methyltransferase (MGMT) status, with response, progression-free survival (PFS), and overall survival. OUTLINE: Patients receive methoxyamine orally (PO) once daily (QD) and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, every 2 months for 2 years, and then every 6 months thereafter.

Conditions

• Adult Brain Glioblastoma

Interventions

Type	Name	Description
OTHER	Treatment	Correlative studies
DRUG	Methoxyamine	Given PO
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2015-12-18
• Primary completion: 2017-02-16
• Completion: 2017-02-16
• First posted: 2015-03-24
• Last updated: 2019-04-04
• Results posted: 2019-04-04

Locations

12 sites across 1 country: United States