Phase I/II Trial of Valproic Acid and Karenitecin for Melanoma
Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute