Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)

NCT02192021 | Completed Phase 1 DMC

• 1 other identifier: STUDY19080323
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will kill tumor cells locally and alter the tumor microenvironment to induce durable systemic tumor-specific immunity. The purpose of this study is to test a new method of experimental treatment for CTCL, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. We also want to determine which micro-dose of the drug is the best to achieve the best response. To make sure that we observe the effects of the very low dose of the drug and not the MNA patch itself, we will also use a placebo (a patch without drug in some patients) in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where the patches are applied. Once the best dose is determined for use in the patch, we will also begin to look at how well the patches work in clearing the skin.

Conditions

Cutaneous T Cell Lymphoma

Keywords

CTCL; Cutaneous T-cell Lymphoma; Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of the micro array needle doxorubicin (MNA-D) system confirmed by vital signs, hematology, comprehensive metabolic panel, assessment for skin toxicity, and adverse event evaluation.

  A traditional 3 + 3 dose escalation design will be used in 4 dosage cohorts (25 ug, 50 ug, 100 ug, and 200 ug).

  9 weeks

Secondary Outcomes (1)

• Evaluate the clinical responses (i.e., effectiveness) by the MNA-D

  12 months

Other Outcomes (1)

• Evaluate the tumor immunity induced by the MNA-D

  12 months

Study Arms (1)

Micro needle array-Doxorubicin (MNA-D)

EXPERIMENTAL

MNA-D application for all subjects

Drug: Micro needle array-Doxorubicin (MNA-D)

Interventions

Micro needle array-Doxorubicin (MNA-D) DRUG

MNA-D patches will be applied to 3-4 CTCL skin patches or plaques at each weekly visit (4/cycle). The initial safety, dose-finding phase will include one cycle of applications and the second phase will include weekly applications (4/cycle) for up to 6-8 cycles.

Also known as: patch, doxorubicin

Micro needle array-Doxorubicin (MNA-D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cutaneous T-cell Lymphoma (CTCL) based upon a skin biopsy diagnostic of atypical epidermotropism of folliculocentric or epidermotropic T-cells.
• Current stage of IA or IB.
• Expected survival of greater than or equal to12 months.
• Not be on any other investigational device/drug treatment.
• Have a sufficient number (i.e., n=4 for first dose cohort in Initial Safety Evaluation; n=3 for remainder of subjects) and surface area (\> 5 cm2) of CTCL patches or plaques for Micro needle array-Doxorubicin (MNA-D) and Micro needle array (MNA) application.
• Willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.
• Have the following initial and subsequent pretreatment laboratory parameters: granulocytes ≥2,000/mm3; platelets \>50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT, , LDH, Alk phos ≤3X the ULN.Subjects must be ³ 18 years of age and must be able to understand the written informed consent/assent document.
• Have no evidence of active infection, regardless of the degree of severity or localization. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for study participation after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics before beginning treatment.
• Not receive any other treatment for CTCL except emollients of subject's choice without topical steroids, anti-fungal or antibacterial topical preparations.
• Willing to discontinue concomitant medications for CTCL for the duration of their study participation, including: high dose topical steroids - 2 week washout; oral steroids above 10 mg - 3 week washout; Psoralen + Ultraviolet A light (PUVA) or ultraviolet B light (UVB) (including sunbathing, tanning beds, etc.) - 2 week washout; extracorporeal photopheresis - 2 week washout; Electron Beam - 2 weeks washout; chemotherapeutic agents - 3 week washout; bexarotene capsules or other oral biologics - 2 week washout; and topical nitrogen mustard - 2 week washout.

You may not qualify if:

• Uncontrolled pain.
• Known history of autoimmune disease; or active HIV, HTLV-1, and/or hepatitis infection.
• Pregnant or lactating.
• Have sensitivity to drugs that provide local anesthesia.
• Have active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix.

Sponsors & Collaborators

• Falo, Louis, MD: lead

Study Sites (1)

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Bediz B, Korkmaz E, Khilwani R, Donahue C, Erdos G, Falo LD Jr, Ozdoganlar OB. Dissolvable microneedle arrays for intradermal delivery of biologics: fabrication and application. Pharm Res. 2014 Jan;31(1):117-35. doi: 10.1007/s11095-013-1137-x. Epub 2013 Aug 1.

  PMID: 23904139 BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Interventions

Transdermal Patch; Doxorubicin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Oleg E Akilov, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 16, 2014
• Study Start: March 9, 2016
• Primary Completion: November 21, 2020
• Study Completion: December 9, 2020
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)