Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02395692|
Recruitment Status : Terminated (Pre-specified response criteria not met to proceed to next stage of study.)
First Posted : March 24, 2015
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adult Brain Glioblastoma||Other: Treatment Drug: Methoxyamine Drug: Temozolomide||Phase 2|
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)
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of TRC102 in Combination With Temozolomide for Recurrent Glioblastoma|
|Actual Study Start Date :||December 18, 2015|
|Actual Primary Completion Date :||February 16, 2017|
|Actual Study Completion Date :||February 16, 2017|
Experimental: Treatment (methoxyamine, temozolomide)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: TRC102
- Objective Response as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria (Arm 1 and Arm 2) [ Time Frame: Up to at least 2 years ]
To test the hypothesis that the combination treatment of temozolomide and methoxyamine will achieve 30% radiographic response rate (partial response + complete response) in patients with first recurrence of glioblastoma.
Per Response Assessment in Neuro-Oncology (RANO) Criteria: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Toxicity as Assessed by Number of Participants Who Experienced Adverse Events [ Time Frame: Up to 30 days following the last dose of study drug ]Number of participants who experience adverse events graded 3 or higher as defined by National Cancer Institute CTCAE v4.0.
- Progression-free Survival [ Time Frame: Up to at least 2 years ]Will be analyzed using standard descriptive statistical methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Progression-free Survival at 6 Months [ Time Frame: 6 months ]Will be analyzed using standard descriptive statistical methods.
- Overall Survival [ Time Frame: Up to at least 2 years ]Will be analyzed using standard descriptive statistical methods.
- MPG, Topo II-alpha, and MGMT Levels in Tissue Samples [ Time Frame: Baseline ]MPG, topo II-alpha, and MGMT levels will be correlated with response, PFS, and overall survival. Will be analyzed using standard descriptive statistical methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395692
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|UCSF Medical Center-Parnassus|
|San Francisco, California, United States, 94143|
|United States, Maryland|
|Adult Brain Tumor Consortium|
|Baltimore, Maryland, United States, 21231-1000|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Henry Ford Cancer Institute¿Downriver|
|Brownstown, Michigan, United States, 48183|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Henry Ford West Bloomfield Hospital|
|West Bloomfield, Michigan, United States, 48322|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Manmeet Ahluwalia||National Cancer Institute (NCI)|