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

Inclusion Criteria:

• Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheralT-cell lymphoma with cutaneous involvement supported by histological evaluation ofskin lesions.

• Participants must have measurable cutaneous disease, based on the modified SeverityWeighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesionssituated in a previously irradiated area are considered measurable if progressionhas been demonstrated in such lesions.

• Two lesions are amenable to placement of multiple devices in terms of lesion sizeand location, as assessed by dermatologist (minimum diameter of 1.5 cm).

• Patient must have the following minimum washout period from previous treatments andcannot 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 dosesof oral corticosteroids (physiologic replacement doses of oral corticosteoidsare 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 forimplantation

• 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 willdetermine the clinically appropriate treatment strategy based on clinical historyand extent of disease. Systemic therapy will be mandatory for cohort 2/expansioncohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeksof MD removal.

• Patients must be deemed medically stable to undergo percutaneous procedures by theirtreating cutaneous oncologist.

• Ability to understand and the willingness to sign a written informed consentdocument.

• Patients must be willing to undergo research-related genetic and transcriptomicsequencing (somatic and germline) and data management, including the deposition ofde-identified genetic sequencing data in NIH central data repositories.

• Patient is considered to have capacity to properly follow instructions at home forthe care of device(s) that will each have an attached thin guidewire protrudingthrough 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 withsurgical or biopsy procedures

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to agents used in this study.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• Patients who will receive standard of care systemic therapy are not allowed to startany new skin directed therapy (e.g. topical steroids, radiation, phototherapy)concurrent with first systemic therapy initiated after device implantation andretrieval. Should a patient clinically progress on first systemic therapy andrequire a change in treatment, skin directed therapies may be introduced.

• Patients unable to undergo treatment wash-out period due to rapidly progressivedisease requiring immediate systemic therapy