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 range18 Years
SexALL
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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…