Phase I/II Trial of Valproic Acid and Karenitecin for Metastatic Malignant Melanoma
Treatment cycles are every 3 weeks and there are 17 study visits in all.
During Phase I subjects will receive one cycle of Karenitecin alone (cycle 1 days 1-5) and
then combination therapy with VPA + Karenitecin (cycle 2 days 1-7)followed by oral VPA in
divided doses for 5 days and Karenitecin starting the third day (days 3-7) every 3 weeks.
After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the
Dose escalations will continue until unacceptable dose limiting toxicity (DLT) occurs, then
dose escalation will be stopped and the previous dose level will be explored. In each dose
level, participants will undergo pharmacokinetic (PK) sampling to determine blood levels.
The melanoma skin lesions will also be biopsied to measure the effect of the combination
All patients enrolled in the Phase II will be treated with VPA and Karenitecin using the
dosing schedule determined to be the MTD in Phase I. In the absence of disease progression
and if there is continued safety and tolerability, treatment may continue in consecutive 3
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile of Valproic Acid (VPA) and Karenitecin
Average of 6 months
Adil Daud, M.D.
UCSF (formerly at H. Lee Moffitt Cancer Center & Research Institute)
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|