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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061449
Recruitment Status : Terminated (Low Accrual)
First Posted : February 12, 2014
Last Update Posted : December 24, 2018
Ludwig Institute for Cancer Research
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Drug: Romidepsin Drug: Poly ICLC Radiation: Focal lesional radiation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of a Novel Multimodality Immuno-Chemotherapy Platform for Patients With Advanced Cutaneous T Cell Lymphoma
Actual Study Start Date : March 2014
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: Initiating therapy with Romidepsin (Arm A)
Patients who are starting therapy with Romidepsin (intravenously on days 1, 8, and 15 of every 21-day cycle or alternate schedule per treating physician) also receive focal lesional radiation on days 1,3, and 5 without (level 1) or with (level 2) Poly ICLC (subcutaneously on days 1, 3, and 5) on the first cycle.
Drug: Romidepsin
Other Names:
  • Istodax
  • FK228
  • FR901228

Drug: Poly ICLC
Radiation: Focal lesional radiation
Experimental: treatment with Romidepsin with SD or PR (Arm B)
Patients with stable disease on the treatment with Romidepsin (intravenously on days 1, 8, and 15 of every 21-day cycle or alternate schedule per treating physician) also receive focal lesional radiation on days 1,3, and 5 without (level 1) or with (level 2) Poly ICLC (subcutaneously on days 1, 3, and 5) on the first cycle.
Drug: Romidepsin
Other Names:
  • Istodax
  • FK228
  • FR901228

Drug: Poly ICLC
Radiation: Focal lesional radiation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have prior biopsy at any time point diagnostic for confirmed MF stage IIA-IVA, and must have failed at least one standard therapy (topical or systemic).
  • Must have a skin lesion of at minimum 2 cm, in a location amenable to radiation and a minimum of 2 additional measurable skin lesions distant from the radiation site.
  • Must be either initiating therapy with romidepsin (Arm A) or currently receiving romidepsin with documented stable disease (SD) or partial response (PR) (Arm B).
  • Patient may have had any prior topical or systemic therapy except for total electron beam irradiation. Patients must be a minimum of 2 weeks from topical therapy and 4 weeks from systemic therapies, phototherapy, or local radiation therapy before enrollment except for HDACI if they are in Arm B. Patients are allowed to take weak potency topical corticosteroids if patient has been on a stable dose for more than a month.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >70%)
  • Life expectancy of greater than 6 months
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes >=2,500/mcL
    • absolute neutrophil count >=1,000/mcL
    • platelets >=50,000/mcL
    • total bilirubin: within normal institutional limits
    • AST(SGOT, aspartate aminotransferase)/ALT(SGPT, alanine aminotransferase) =<2.5 X institutional upper limit of normal
    • creatinine: within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Age >=18 years
  • The effects of focal radiation and HDACI on the developing human fetus are unknown. For this reason and because agents as well as other therapeutic agents used in this trial are known to be tetragenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks, or topical therapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients are allowed to take weak potency topical corticosteroids if patient has been on a stable dose for more than a month.
  • Patients who are receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to HDACI, TLR-agonist, or patients with known history of pre-existing auto-immune disease.
  • Concurrent therapy with systemic corticosteroids or other immunosuppressive medications.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study HDACI is a class agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with HDACI, breastfeeding should be discontinued if the mother is treated with HDACI and radiation. Woman of childbearing age and men sexually active with woman of childbearing age must agree to an acceptable method of birth control (double barrier) while on study.
  • Patients with known HIV infection are ineligible because this immunomodulatory therapy requires a normal and functional T cell repertoire. If this study is found to be safe, effective, and immunogenic, HIV positive patients may be included in future studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061449

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United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Ludwig Institute for Cancer Research
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Principal Investigator: Catherine Diefenbach, MD NYU Langone Health

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Responsible Party: NYU Langone Health Identifier: NCT02061449    
Other Study ID Numbers: 13-00686
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Toll-like receptor agonist
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Poly I-C
Carboxymethylcellulose Sodium
Antibiotics, Antineoplastic
Antineoplastic Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents