Phase I Trial Of Temozolomide Combined With The Histone Deacetylase Inhibitor Valproic Acid (VPA) And Whole Brain Radiation Therapy (WBR) For Brain Metastases From Solid Tumors In Adults
At the start of the study, patients will be informed which dose level they will be treated
with. On day 1, patients will have a physical exam and several blood draws including draws
to measure the level of valproic acid in their body. Patients will start your whole brain
radiation and also at the same time start the valproic acid and temozolomide pills. Patients
will be asked to take the valproic acid pills every 12 hours and the temozolomide pills once
daily. Patients will not need to come to the center for that but will need to come to the
center to receive you whole brain radiation for 3 weeks (on weekdays, excluding holidays).
Radiation therapy will not be administered on weekends but patients will still take their
pills for the whole 3 weeks from starting the radiation.
Patients will have to come back for a study visit weekly for the 6 months. Two more visits
are also required: approximately 6 weeks and 10 weeks from starting the treatment. Patients
will be asked about any old or new symptoms to determine if adjustment in the pill dose is
Every study visit except the last one will include blood draws. These will evaluate blood
counts, blood chemistry and also measure the level of valproic acid in your body. The Mini
Mental Status examination described above will be repeated in every visit.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of temozolomide in combination with VPA and Whole-Brain Radiation
approximately 74 days per patient
Sajeel Chowdhary, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|