Spots Global Cancer Trial Database for Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma
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Trial Identification
Brief Title: Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma
Official Title: Phase II Study of TRC102 in Combination With Temozolomide for Recurrent Glioblastoma
Study ID: NCT02395692
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
Adult Brain Tumor Consortium, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Henry Ford Cancer Institute¿Downriver, Brownstown, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Contact Details
Name: Manmeet Ahluwalia
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
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