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

Not Recruiting

Trial ID: NCT02542124


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)

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology


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

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


biological: NM-IL-12 and TSEBT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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