Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Poly ICLC

Romidepsin

Interferons

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Histone Deacetylase Inhibitors

Enzyme Inhibitors

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.

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.

Focal lesional radiation

Catherine Diefenbach, MD

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.

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.

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

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

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.

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.

Overall survival is described as the time from study entry to the date of death due to any cause.

Ludwig Institute for Cancer Research

NYU Langone Health

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

primarily resectable pancreatic cancer patients

neoadjuvant Radiation of 0,5 Gy two days before resection

neoadjuvant Radiation of 2 Gy 2 days before resection

neoadjuvant Radiation of 5 Gy 2 days before resection

single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection

neoadjuvant photon radiation

single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Peter E. Huber, Prof. PhD MD

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.

Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity

local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls

surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment

frequencies of tumor-reactive T-cells in blood and bone marrow

expression of migration-relevant adhesion molecules on tumor endothelial cells

expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood

quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Poly ICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma	NCT02061449	Cutaneous T-cel...	Romidepsin Poly ICLC Focal lesional ...	18 Years -	NYU Langone Health
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer	NCT01027221	Primarily Resec...	neoadjuvant pho... neoadjuvant pho... neoadjuvant pho...	50 Years -	German Cancer Research Center
Poly ICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma	NCT02061449	Cutaneous T-cel...	Romidepsin Poly ICLC Focal lesional ...	18 Years -	NYU Langone Health

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