Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients (NCT02654041) | Clinical Trial Compass
TerminatedPhase 2
Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients
Stopped: Drug manufacturer no longer could supply for study
Israel3 participantsStarted 2016-03
Plain-language summary
The objective of the study is to assess the safety and efficacy of treatment with hypothyroxinemia adjunct to conventional therapies in GBM patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of GBM, histologically or cytologically confirmed.
* Newly-diagnosed subjects prior to beginning first-line conventional therapy.
* Male or female subjects 18 years of age or older.
* Ability to understand and willingness to sign a written informed consent document.
* Ability and consent to comply with completion of a patient diary.
* Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) with conventional techniques or as ≥10 mm (≥1 cm) with spiral CT scan, MRI, or calipers by clinical exam.
* Allowable type and amount of prior therapy and medication
* ECOG performance status ≤2 (KPS ≥60%, see Appendix A).
* Life expectancy of greater than 6 months
* Subjects must have adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
* Total bilirubin \< 1.5 x the upper limit of normal (ULN).
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< 2.5 xULN (\< 5 x ULN for subjects with liver involvement of their cancer).
* Alkaline phosphatase limit \< 2.5 x ULN (\<5 x ULN for subjects with liver involvement of their cancer)
* Serum creatinine \< 1.5 x the ULN. Glomerular filtration rate (GFR) ≥ 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal diseas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.