A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : belinostat
Phase: Phase 2
Ages Eligible For Study:
- Male or female with age > or = 18 years. - Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL). - Must have failed at least one line of prior systemic therapy. No limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible. - The presence of measurable disease (defined as > or = 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT). - Adequate bone marrow and hepatic function including the following: - Absolute neutrophil count > or = 1,000 cells/mm3, platelets > or = 40,000/mm3 - Total bilirubin < or = 1.5 x upper normal limit or < or = 3 x upper normal limit if hepatic involvement - AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine aminotransferase) < or = 2.5 x upper normal limit (< or = 5 x upper normal limit if hepatic involvement) - Hemoglobin > or = 9.0 g/dL. - Serum potassium within normal range. - Karnofsky performance status > or = 70%. - Estimated life expectancy > 3 months. - Signed informed consent approved by the Institutional Review Board (IRB).