NM-IL-12 in Cutaneous T-Cell Lymphoma (CTCL) Undergoing Total Skin Electron Beam Therapy (TSEBT)

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CLINICAL TRIALS

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CLINICAL TRIALS

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Trial ID or NCT#

NCT02542124

Status

NOT 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

Inclusion Criteria:

1. 18 years of age or older 2. Biopsy-confirmed CD4+ mycosis fungoides or Sézary syndrome, stage IB to IIIB 3. The patient is eligible for TSEBT 4. Eastern Cooperative Oncology Group (ECOG) of ≤ 2. 5. Adequate bone marrow function: WBC > 2000/μL; platelet count > 75,000/μL; Neutrophil count > 1000/μL, without use of colony stimulating factors (CSF). 6. Required washout period for prior therapies Topical therapy: 2 weeks - Phototherapy (PUVA): 4 weeks - Local Skin Radiation Therapy (< 10% skin surface): 4 weeks - Retinoids: 4 weeks - Interferons: 4 weeks - Low dose methotrexate: 4 weeks - HDAC inhibitors: 8 weeks 7. Women of child-bearing potential must have negative serum pregnancy test and use accepted highly effective methods of birth control throughout the study and for 90 days after dosing and must agree to use effective contraception. 8. Male patients must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception during the study and for 90 days after dosing. 9. Adequate hepatic function: bilirubin ≤1.5 x upper limit of normal (ULN), AST ≤2.5 x ULN, ALT ≤2.5 x ULN, alkaline phosphatase (liver fraction) ≤2.5 x ULN 10. Adequate renal function: creatinine ≤1.5 x ULN 11. Ability to comply with the treatment schedule

Exclusion Criteria:

1. Biopsy confirmed CD8+ CTCL histology 2. Large cell transformation 3. Prior systemic use of any immunosuppressive chemotherapy (except low dose methotrexate) and/or monoclonal antibody treatment for CTCL 4. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study). 5. Concomitant use of any anti-cancer therapy or immune modifier. 6. Prior allogeneic hematopoietic cell transplant. 7. Any ongoing infection whether receiving or not receiving antibiotics or have received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug. 8. Known history of human immunodeficiency virus (HIV), hepatitis B or C 9. For women on estrogen based contraceptives, family history of venous thromboembolism (VTE) and/or risk factors predisposing for VTE and other medical conditions known to be associated with VTE. 10. History of prior malignancy with the exception of cervical intraepithelial neoplasia, non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <1.0). Patients with a history of other malignancies must have undergone potentially curative therapy and have no evidence of that disease for five years 11. Uncontrolled intercurrent illness, condition, or circumstances that could limit compliance with the study, including, but not limited to the following: acute or chronic graft versus host disease, uncontrolled diabetes mellitus or hypertension, or psychiatric conditions 12. Any other medical issue, including laboratory abnormalities, deemed by the Investigator to be likely to interfere with patient participation 13. Unresolved toxicity from previous anticancer therapy or incomplete recovery from surgery 14. Major surgery within 12 weeks of enrolment 15. Medically significant cardiac event or unstable cardiovascular function defined as: - Symptomatic ischemia, unstable angina pectoris - Uncontrolled clinically significant cardiac arrhythmia - Symptomatic heart failure NYHA Class ≥ 3 - Myocardial infarction or cardiac surgery within 6 months prior to enrollment 16. Cerebrovascular event (transient ischemic attack, stroke or CNS bleeding) within the last 12 months. 17. Major bleeding within the last 6 months. 18. Use of any investigational agents within 30 days prior to enrollment and for the duration of the study 19. Pregnant or lactating 20. Unwilling or unable to provide informed consent

View All Criteria

Investigator(s)

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

Medical oncologist, Lymphoma specialist, Cutaneous oncology specialist, Hematologist

Assistant Professor of Medicine (Oncology) and of Dermatology

CONTACT

CCTO
(650) 498-7061

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CONTACT

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Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: