A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma
Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation,
inhibits proliferation, and induces apoptosis. Pivanex has been generally well tolerated in
clinical trials and has shown preliminary evidence of efficacy in patients with non-small
cell lung cancer. Pivanex has shown in-vitro and in-vivo evidence of anti-tumor activity
against melanoma and, therefore, represents a promising therapeutic approach to patients
with malignant melanoma.
Purpose: This open-label trial will determine the response rate of Pivanex in patients with
- Determine time to disease progression
- Determine overall survival
- Determine the safety profile of Pivanex in malignant melanoma
Outline: This is an open-label, single center study in patients with malignant melanoma
whose disease has progressed or failed to respond to chemotherapy or Interleukin-2 (IL-2).
Patients will be treated with 2.5 g/m2 of Pivanex administered intravenously over 6 hours
daily on Days 1 – 3.
Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn
from treatment for other protocol-specified reasons. Tumor status will be assessed prior to
every odd-numbered treatment cycle using the Response Evaluation Criteria in Solid Tumors
(RECIST) method. Patients who continue to experience tumor response or stabilization at the
time treatment is discontinued will be followed every 12 weeks for tumor status until
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
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