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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: New York University School of Medicine

Current Primary Outcome: Maximum tolerated dose (MTD) [ Time Frame: 21 days ]

Adverse events and dose-limiting toxicities will be graded using National Cancer Institute's Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate [ Time Frame: Up to 12 months ]
    Defined as the percentage of patients who achieve complete response or partial response. The response is evaluated based on Modified Severity weighted Assessment Tool (MSWAT) criteria.
  • Median progression-free survival [ Time Frame: up to 12 months ]
    Progression-free survival is defined as the time from study entry to the first documented of tumor progression ot death due to any cause whichever comes first.
  • Median overall survival [ Time Frame: up to 12 months ]
    Overall survival is described as the time from study entry to the date of death due to any cause.


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: February 11, 2014
Date Started: March 2014
Date Completion: December 2017
Last Updated: December 28, 2016
Last Verified: December 2016