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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

NCT01468818

Metastatic Melanoma Skin Cancer

TERMINATED PHASE2

Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes

NCT01236573

Skin Cancer Metastatic Melanoma

TERMINATED PHASE1/PHASE2

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

NCT01993719

Metastatic Melanoma

COMPLETED PHASE2

Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides

NCT00052377

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Stage I Cutaneous T-cell Non-Hodgkin Lymphoma +7 more

TERMINATED PHASE1/PHASE2

Immunotherapy Using 41BB Selected Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

NCT02111863

Melanoma Skin Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single arm, open-label, non-randomized study with NM-IL-12 dosed in combination with low dose TSEBT in CTCL patients. This study is planned to be conducted in 10 patients, 18 years or older in age, undergoing low dose TSEBT of 12 Gy over a 3-week period.

The study will initially enroll 4 patients and then will be expanded to enroll 6 additional patients (total 10 patients) depending on the presence or absence of Dose Modifying Criteria (DMC). Decision whether to de-escalate will be made after first 4 patients are followed up for 28 days from the first dose of NM-IL-12.

Safety monitoring will continue throughout the whole period of drug administration and the treatment will be discontinued if intolerable toxicity or disease progression occurs during this period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous T Cell Lymphoma (CTCL) Mycosis Fungoides Sézary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NM-IL-12 and TSEBT

TSEBT and subcutaneous doses of NM-IL-12

Group Type EXPERIMENTAL

NM-IL-12 and TSEBT

Intervention Type BIOLOGICAL

The LD-TSEBT treatment will start on Day 1 of the study. NM-IL-12 will be administered subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NM-IL-12 and TSEBT

The LD-TSEBT treatment will start on Day 1 of the study. NM-IL-12 will be administered subcutaneously.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HemaMax, rHu-IL12, LD-TSEBT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No