Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients
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|ClinicalTrials.gov Identifier: NCT02654041|
Recruitment Status : Terminated (Drug manufacturer no longer could supply for study)
First Posted : January 13, 2016
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme (GBM)||Drug: Combined T3 and Methimazole treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II, Open-label, Prospective, Single-arm, Single-center Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Hypothyroxinemia induced patients
Combined T3 and Methimazole treatment will be administered. This experimental treatment will be administered adjunct to standard oncological treatment for newly-diagnosed GBM patients e.g. radiation followed by Temozolomide.
Drug: Combined T3 and Methimazole treatment
Oral administration of T3 and Methimazole
- Response rate at 6 months (6 months PFS) [ Time Frame: 32 weeks ]The primary outcome measure of the study is the ratio of patients who complete their 6-month course of chemotherapy given the IP adjunct treatment. Each patient is treated up to 6 weeks until their FT4 target is reached at which time they enter a 26 week (6 month) treatment phase during which they receive chemotherapy as per common protocol with the IP as adjunct treatment. Patients will be monitored for disease progression as per common oncological protocol (e.g. every 2 months) and those who show progression will be deemed failures. Patients with no disease progression (or partial or complete remission) at the end of the 6 month period will be considered success.
- Response rate at 2 months (2 months PFS) [ Time Frame: 14 weeks ]As a secondary outcome we will measure 2 month progression free survival as measured by RANO.
- Response rate at 4 months (4 months PFS) [ Time Frame: 23 weeks ]As a secondary outcome we will measure 4 month progression free survival as measured by RANO.
- Time to disease progression or cancer-related death [ Time Frame: 32 weeks ]
- Safety endpoint evaluation [ Time Frame: 32 weeks ]Patients will be monitored throughout the study period for any Hypothyroxinemia treatment related safety issues including serious adverse events, any adverse events, vital signs, lab assessment, physical examination and lung function.
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): NCT02654041
|Tel-Aviv Medical Center, Israel|
|Tel-Aviv, Israel, 64239|
|Principal Investigator:||Deborah T Blumenthal, MD||Tel-Aviv Medical Center, Israel|