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Anti-tumor antibiotic

MNA-D Patches for Cutaneous T-Cell Lymphoma (MNA-D Trial)

Phase 1

Waitlist Available

Led By Oleg E Akilov, MD, PhD

Research Sponsored by Falo, Louis, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Cutaneous T-cell Lymphoma (CTCL) based upon a skin biopsy diagnostic of atypical epidermotropism of folliculocentric or epidermotropic T-cells

Not receive any other treatment for CTCL except emollients without specified topical medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

MNA-D Trial Summary

This trial is testing a new method of experimental treatment for CTCL, using small adhesive-like patches with very small micro-needles loaded with extremely low doses of doxorubicin. The goal is to test the safety and effectiveness of these patches, determine the best micro-dose of the drug, and evaluate the skin where the patches are applied.

Who is the study for?

This trial is for adults with Cutaneous T-cell Lymphoma (CTCL) who have not used certain treatments recently, like high dose steroids or chemotherapy. They should have a life expectancy of over 12 months and no uncontrolled pain, autoimmune diseases, active infections like HIV or hepatitis, or be pregnant. Participants need enough affected skin area to apply the patches and must agree to use only emollients without steroids during the study.Check my eligibility

What is being tested?

The trial tests a new treatment using micro-needle patches coated with low doses of doxorubicin on CTCL patients. It aims to find the safest and most effective dose while assessing if these patches can clear up affected skin areas. Some participants will receive placebo patches without medication as part of the study's comparison process.See study design

What are the potential side effects?

Potential side effects may include local skin reactions where the patch is applied due to doxorubicin such as redness, swelling, or pain. There could also be general chemotherapy-related side effects like fatigue, nausea, hair loss but at possibly lower levels given the micro-dosing approach.

MNA-D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CTCL based on a skin biopsy.

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I am only using moisturizers for my skin cancer, no other treatments.

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I am not currently participating in any other clinical trials.

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I have enough skin patches or plaques for treatment application.

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I am 18 or older and can understand the consent form.

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My cancer is in an early stage (IA or IB).

MNA-D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

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

Other outcome measures

Evaluate the tumor immunity induced by the MNA-D

MNA-D Trial Design

1Treatment groups

Experimental Treatment

Group I: Micro needle array-Doxorubicin (MNA-D)Experimental Treatment1 Intervention

MNA-D application for all subjects

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Falo, Louis, MDLead Sponsor

1 Previous Clinical Trials

48 Total Patients Enrolled

Oleg E Akilov, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh

3 Previous Clinical Trials

109 Total Patients Enrolled

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02192021 — Phase 1

Cutaneous T-Cell Lymphoma Research Study Groups: Micro needle array-Doxorubicin (MNA-D)

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02192021 — Phase 1

Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02192021 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other research studies explored the efficacy of Micro needle array-Doxorubicin (MNA-D)?

"Presently, the number of medical trials investigating Micro needle array-Doxorubicin (MNA-D) is 360 with 119 in Phase 3. While Providence, Rhode island holds many MNA-D studies, there are 23596 sites offering this medication worldwide."

Answered by AI

How many individuals are eligible to participate in this medical research?

"Affirmative. As per the information on clinicaltrials.gov, this experiment is currently seeking participants; an initiative that was launched on March 9th 2016 and revised for the last time June 2nd 2022. 54 subjects need to be sought from a single medical facility."

Answered by AI

Has the Federal Drug Administration sanctioned Micro needle array-Doxorubicin (MNA-D) for therapeutic purposes?

"As this is a Phase 1 trial, with limited data to support its efficacy and safety, the team at Power assessed MNA-D's risk profile as low (rating of 1)."

Answered by AI

Does this trial represent a pioneering approach to research?

"To date, 360 clinical trials surrounding Micro needle array-Doxorubicin (MNA-D) are ongoing throughout 1941 cities in 66 countries. The first MNA-D study was launched by Alfacell and comprised of 300 participants back in 1997. Since then, 677 studies have been successfully concluded with the final phase 3 drug approval stage being reached for many of them."

Answered by AI

Are there any vacancies left for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov displays the fact that this research project, first advertised on March 9th 2016, is in its recruitment phase. 54 people are being sought out at a single site to participate in the trial."

Answered by AI

To which diseases or conditions is Micro needle array-Doxorubicin (MNA-D) typically applied?

"Micro needle array-Doxorubicin (MNA-D) is a viable option for the treatment of lymphoma, hodgkins and other varieties of carcinomas such as bronchogenic or neuroblastoma. Additionally, MNA-D can be utilized to address Sezary Syndrome."

Answered by AI

Recent research and studies

Pharmaceutical ResearchJournal

Dissolvable Microneedle Arrays for Intradermal Delivery of Biologics: Fabrication and Application

Bediz, Bekir, Emrullah Korkmaz, Rakesh Khilwani, Cara Donahue, Geza Erdos, Louis D. Falo Jr, and O. Burak Ozdoganlar. 2013. “Dissolvable Microneedle Arrays for Intradermal Delivery of Biologics: Fabrication and Application”. Pharmaceutical Research. Springer Science and Business Media LLC. doi:10.1007/s11095-013-1137-x.

clinicaltrials.govStudy

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

Oleg E. Akilov, MD, PhD 2016. "Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02192021.

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