Recruiting

MicrodeviceA Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04045470

Conditions

Cutaneous T Cell Lymphoma

Peripheral T Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microdevices

Standard of care therapy

Standard of care systemic therapy

Study Details

Brief summary:

This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a cancerous lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma and peripheral T cell lymphoma

Conditions

Cutaneous T Cell Lymphoma

Peripheral T Cell Lymphoma

Study ID

NCT04045470

Start date

Dec 11, 2019

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by histological evaluation of skin lesions.
Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Two lesions are amenable to placement of multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum diameter of 1.5 cm).
Patient must have the following minimum washout period from previous treatments and cannot be on any systemic therapy at the time of implantation.

2 week from topical therapies of lesional skin selected for implantation
2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed)
4 weeks from phototherapy
5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy
12 weeks from local radiation therapy of lesional skin selected for implantation
15 weeks from systemic immunotherapy targeting PD-1/PD-L1
Age minimum of age 18.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below:

absolute neutrophil count ≥500/mcL
platelets ≥50,000/mcL
Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for cohort 2/expansion cohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD removal.
Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist.
Ability to understand and the willingness to sign a written informed consent document.
Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
Patient is considered to have capacity to properly follow instructions at home for the care of device(s) that will each have an attached thin guidewire protruding through the skin and fixed in place (see Appendix B).

Exclusion Criteria:

Positive serum pregnancy test at screening visit.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced.
Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Initial Cohort

Patients with plaque or tumor skin lesions of cutaneous T cell lymphoma or peripheral T cell lymphoma
Mandatory skin biopsy for corollary studies will be obtained
Patients will undergo percutaneous placement of four total microdevice(s) into two skin lesions (2 MD per skin lesion)

experimental: Expansion Cohort

Only patients with plaque or tumor skin lesions of cutaneous T cell lymphoma or peripheral T cell lymphoma who plan to start systemic therapy as part of standard of care
Mandatory skin biopsy for corollary studies will be obtained
Patients will undergo percutaneous placement of four total microdevice(s) into two skin lesions (2 MD per skin lesion)
Participants will receive standard of care therapy and clinical course followed
Participants will undergo standard of care therapy as previously determined by treating oncologist and/or dermatologist prior to enrollment to study
Participants will not be assigned any treatment intervention

Interventions

Microdevices

The microdevice was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer.

Standard of care therapy

Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy

Standard of care systemic therapy

Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy.

Primary outcome measure

To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal [ Time Frame: 2 years ]
To Retrieve The Device With Sufficient Tissue Of Sufficient Quality [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Cecilia Larocca, MD

617-632-6571 clarocca@partners.org

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Cecilia Larocca, MD

617-632-6571 clarocca@partners.org

Principal Investigator:

Cecilia Larocca, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

Cutaneous T Cell Lymphoma
Peripheral T Cell Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-27.