NCT02061449

Poly ICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma

A Pilot Study of a Novel Multimodality Immuno-Chemotherapy Platform for Patients With Advanced Cutaneous T Cell Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and tolerability of the addition of immunostimulatory therapy consisting of focal radiation with or without the Toll-like receptor (TLR) agonist Poly ICLC in patients with cutaneous T-cell lymphoma (CTCL) receiving concurrent therapy with the histone deacetylase inhibitor (HDACI) Romidepsin.

Detailed description

Histone deacetylase inhibitors in epigenetic therapy are one of the most active anti-tumor agents in patients with relapsed and refractory CTCL despite their suppressive effects on T cell function, yet the overall response rate and response duration with these agents remains suboptimal. Immune stimulatory agents may be the ideal therapy to combine with HDACI. To date, no one has evaluated whether the abscopal effect of radiation with and without the additional immune stimulation of a TLR-3 agonist can augmented the efficacy of anti-tumor directed epigenetic therapy in mycosis fungoides (MF) patients. The investigators hypothesize that a combined modality immuno-chemotherapy may be highly effective in patients with advanced MF. This is a phase I study. It involves two arms of patients (A and B) who will be treated following a standard 3+ 3 design. Patients on Arm A are the ones who are initiating HDACI therapy, and patients on Arm B are the ones with stable disease or partial response with HDACI treatment. Both groups receive HDACI, plus at level 1, focal lesional radiation; at level 2, radiation in combination with Poly ICLC. Each arm will be evaluated and escalated independently.

Conditions

• Cutaneous T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Romidepsin
DRUG	Poly ICLC
RADIATION	Focal lesional radiation

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-11-05
• Completion: 2018-11-05
• First posted: 2014-02-12
• Last updated: 2018-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study