Cutaneous T Cell LymphomaPhase 1MNA-DNCT02192021
Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)
A Phase 1 study testing Micro needle array-Doxorubicin (MNA-D) in people with Cutaneous T Cell Lymphoma, run by Falo, Louis, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- What is being tested?
- Micro needle array-Doxorubicin (MNA-D)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2016to 9 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
- May re-enroll in the study if greater than 4 weeks elapses between courses and if all other inclusion/exclusion criteria are met.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
About this study
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)
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.
Read the detailed description
This study will evaluate a novel approach to the treatment of patches and plaques in the skin of patients diagnosed with cutaneous t-cell lymphoma utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. We will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous T-cell lymphoma cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses. Importantly, doxorubicin is currently in clinical use with a well-established safety profile. It is anticipated that use of the MNA-Doxorubicin (MNA-D) delivery system will enable direct and specific delivery of chemotherapy to the tumor, thereby avoiding any potential for systemic toxicity. The study will be conducted in two phases, with the first being a safety dose-finding phase and the second phase for efficacy and safety evaluation. The first phase is now completed.
- Conditions
- Cutaneous T Cell Lymphoma
- Being tested
- Micro needle array-Doxorubicin (MNA-D)
- Keywords
- CTCL, Cutaneous T-cell Lymphoma, Mycosis Fungoides
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro needle array-Doxorubicin (MNA-D)Drug
Also called patch, doxorubicin
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.
| Study group | Role | What they receive |
|---|---|---|
| Micro needle array-Doxorubicin (MNA-D) | Experimental | MNA-D application for all subjects Receives: Drug: Micro needle array-Doxorubicin (MNA-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 weeks
Secondary outcomes (1)
Evaluate the clinical responses (i.e., effectiveness) by the MNA-D
We will evaluate local, locoregional, and distant tumor regression; characterize and compare treated skin and the tumor microenvironment before, during, and after therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start9 Mar 2016
- Primary completion21 Nov 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Falo, Louis, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleg E. Akilov, MD, PhD, University of Pittsburgh
- Investigators
- Oleg E Akilov, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192021
- Sponsor's protocol ID
- STUDY19080323
- Acronym
- MNA-D
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2014
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23904139
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02192021
- Acronym / sponsor ID
- MNA-D / STUDY19080323
- Conditions
- Cutaneous T Cell Lymphoma
- Keywords
- CTCL, Cutaneous T-cell Lymphoma, Mycosis Fungoides
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Falo, Louis, MDUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will evaluate a novel approach to the treatment of patches and plaques in the skin of patients diagnosed with cutaneous t-cell lymphoma utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. We will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous T-cell lymphoma cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses. Importantly, doxorubicin is currently in clinical use with a well-established safety profile. It is anticipated that use of the MNA-Doxorubicin (MNA-D) delivery system will enable direct and specific delivery of chemotherapy to the tumor, thereby avoiding any potential for systemic toxicity. The study will be conducted in two phases, with the first being a safety dose-finding phase and the second phase for efficacy and safety evaluation. The first phase is now completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro needle array-Doxorubicin (MNA-D) | Experimental | Drug: Micro needle array-Doxorubicin (MNA-D)MNA-D application for all subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro needle array-Doxorubicin (MNA-D)Also: patch, doxorubicinMNA-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. | Drug | Micro needle array-Doxorubicin (MNA-D) |
Primary outcome
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).
1 secondary outcome
Evaluate the clinical responses (i.e., effectiveness) by the MNA-D
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 23904139Bediz 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.
- Individual participant dataSharing planned: No
Related trials for Cutaneous T Cell Lymphoma
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Cutaneous T Cell Lymphoma
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg E Akilov, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Micro needle array-Doxorubicin (MNA-D) in people with Cutaneous T Cell Lymphoma, run by Falo, Louis, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.