Malignant Melanoma Clinical Trial
Official title:
Phase I/II Trial of Valproic Acid and Karenitecin for Metastatic Malignant Melanoma
This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to
treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity
(DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has
acceptable side effects and recommend a Phase II dose level.
There will be seven escalating doses of Valproic acid and one dose escalation step of
Karenitecin. Each patient shall receive one cycle of Karenitecin alone (cycle 1 days 1 - 5)
followed by the same dose of Karenitecin given in combination with VPA (cycle 2 days 1-7).
Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the
3rd day every 3 weeks (a treatment cycle).
Treatment will continue until progression of disease or an unacceptable level of toxicity.
After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the
disease. In the absence of disease progression and if there is continued safety and
tolerability, treatment may continue.
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
disease.
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
therapy.
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
week cycles.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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