Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL) (MNA-D)
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|ClinicalTrials.gov Identifier: NCT02192021|
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : November 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T Cell Lymphoma||Drug: Micro needle array-Doxorubicin (MNA-D)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Single-Arm, Open-Label, Dose Escalation Trial of MNA-Doxorubicin (MNA-D) in Patients-Subjects With Cutaneous T-cell Lymphoma (CTCL)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Micro needle array-Doxorubicin (MNA-D)
MNA-D application for all subjects
Drug: Micro needle array-Doxorubicin (MNA-D)
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.
- 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. [ Time Frame: 9 weeks ]A traditional 3 + 3 dose escalation design will be used in 4 dosage cohorts (25 ug, 50 ug, 100 ug, and 200 ug).
- Evaluate the clinical responses (i.e., effectiveness) by the MNA-D [ Time Frame: 12 months ]We will evaluate local, locoregional, and distant tumor regression; characterize and compare treated skin and the tumor microenvironment before, during, and after therapy
- Evaluate the tumor immunity induced by the MNA-D [ Time Frame: 12 months ]Generalized skin changes, tissue and blood will be analyzed for immunologic response to the MNA-D in treated and control control cutaneous T-cell lymphoma lesions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192021
|Contact: Sue A McCann, MSN, RNemail@example.com|
|Contact: Oleg Akilov, MD, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University Of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Sue McCann 412-864-3681 email@example.com|
|Contact: Oleg E. Akilov, MD, PhD 412-864-3681 firstname.lastname@example.org|
|Sub-Investigator: Louis D Falo, MD, PhD|
|Sub-Investigator: Sue A McCann, MSN, RN|
|Principal Investigator: Oleg Akilov, MD, PhD|
|Sub-Investigator: Timothy Patton, DO|
|Sub-Investigator: J. Desiree Douglas, PA-C|
|Principal Investigator:||Oleg E Akilov, MD, PhD||University of Pittsburgh|