Combining Radiotherapy and Temozolomide With Dichloracetate in Patients With Newly Diagnosed Glioblastoma
(tylko dawka DCA zdecydowanie za mala - 3mg/kg)
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloracetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
Further study details as provided by Alberta Cancer Board:
Primary Outcome Measures:
* Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
* To determine if there is a correlation between MGMT promoter methylation status and progression-free survival for newly diagnosed GBM patients undergoing concurrent TMZ, DCA and RT followed by six monthly cycles of TMZ and DCA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: Dichloroacetate (DCA)
DCA starting at an initial dose of 3mg/kg twice daily PO for consecutive days (days 1-5) on a 28 days cycle up to 6 cycles unless evidence of tumour progression. Each dose to be administered with food at the same time everyday 12 hours apart.
Detailed Description:
Patients with newly diagnosed Glioblastoma Multiforme Tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (TMZ) with DCA in pill form (twice a day) during the radiation phase of the study and then with TMZ for six months after. Other elements of the clinical trial include pharmacokinetics and MGMT genetic testing.