Trial ID or NCT#

NCT02542124

Status

not recruiting iconNOT RECRUITING

Purpose

In the proposed study, NM-IL-12 will be evaluated as immunotherapy to increase antitumor efficacy against CTCL, while reducing skin-related toxicity, when combined with low-dose TSEBT therapy. Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned in this study, rather, a pre-defined starting dose will be explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy volunteers.

Official Title

A Single Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL-12) In Patients With Cutaneous T Cell Lymphoma (CTCL) Undergoing Low Dose Total Skin Electron Beam Therapy (TSEBT)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Michael Khodadoust
Michael Khodadoust
Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist
Assistant Professor of Medicine (Oncology) and of Dermatology

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CONTACT

CCTO
(650) 498-7061