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