This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best response, 8 cycles, disease progression or intolerability whichever comes first. Importanly, doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed until disease progression or death whichever comes first.
A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax®) in Combination With Doxorubicin HCl Liposomal (Doxil®) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma
This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior line of systemic therapy.
MTD will be determined by standard "3+3" dose escalation of romidepsin with a fixed dose of doxorubicin HCl liposomal. Participants will be followed throughout therapy and all adverse events recorded, graded, and given likelihood of relevance to study therapies. Toxicity will be graded by the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin lesions will be punch biopsied (two contiguous 5mm biopsies) prior to beginning therapy as standard care of care. Any leftover tissue will be collected for research with consent of patient. Optional single 5mm punch biopsies will be obtained on day 15 of Cycle 2 after infusion of romidepsin, and at disease relapse.
Lymphoma T-Cell Lymphoma Cutaneous Lymphoma T-Cell Cutaneous Doxil romidepsin skin Doxorubicin Liposomal doxorubicin Histone Deacetylase Inhibitors
Open to people ages 18 years and up
Laboratory test results within these ranges:
Any known cardiac abnormalities including:
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