Glioblastoma Clinical Trial
Official title:
Phase IIA Trial of Dichloroacetate in Glioblastoma
Dichloroacetate (DCA), the prototypic PDK inhibitor, readily crosses the blood-brain barrier and represents an entirely new class of small molecule metabolic modulators that act in mitochondria to reset cellular homeostasis in various congenital and acquired metabolic disorders. Indeed, pharmacological inhibition of PDK in cancer cells by DCA restores PDC activity, reverses the Warburg effect and induces a caspase-mediated selective apoptosis of tumors. The central hypothesis is that patients treated with DCA prior to surgery will have a significant (p ≤ 0.05) mean decrease in phosphorylated PDC protein expression in tumor tissue, compared to tissue from patients who are not treated before surgery.
Primary Objective: Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. Secondary Objectives: (1) Compare intratumoral biochemical correlates in tumor tissue excised from DCA-treated and DCA-non- treated subjects. Based on the patients' initial tumor resection, MGMT promoter status will be known; however, in this small study, such information will only be used in exploratory post hoc comparisons. (2) Determine two (or longer) year survival in all post- surgical subjects receiving DCA. Subjects will be followed in clinic every two months with standard of care brain imaging and laboratory studies, including plasma trough DCA levels and a clinical neurological exam. Forty study participants, ages 18-80 years, previously diagnosed with a glioblastoma multiforme (GBM) who have experienced tumor recurrence as determined by neuroimaging and some degree of symptomatology (e.g., headache, mental status change, seizure) and have clinically indicated tumor debulking surgery planned. All subjects will have completed initial, standard therapy with surgical debulking, followed by radiation and temozolomide (TMZ) and will, therefore, be considered treatment failures. Study participants will be recruited throughout the United States. ;
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