Microdevice for In Situ Candidate Drug Screening in Skin Lesions of T-Cell Lymphoma

Inclusion Criteria

• Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement in the opinion of the treating dermatologist or medical oncologist based upon available clinical data including pathology reports from non-study institution (if applicable)
• Participants must have cutaneous disease amenable to measurement by mSWAT. Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• One or two lesions are amenable to placement of at least one device in terms of lesion size and location, as assessed by dermatologist (plaque or tumor lesion of a minimum diameter of 1.5 cm, and the epidermis and dermis is clinically suspected to be at least 4 mm in depth)
• Participant 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
• Participants unable to undergo treatment wash-out period due to actively progressive disease requiring immediate systemic therapy are eligible if they may safely delay initiation of next therapy to allow for microdevice implantation and retrieval (e.g. typically within 1-2 weeks) in the opinion of their treating medical or cutaneous oncology provider. Participants with stable disease on systemic therapy must undergo washout period
• Age minimum of age 18
• Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 60%)
• Absolute neutrophil count >= 500/mcL (within 28 days prior to the procedure)
• Platelets >= 50,000/mcL (within 28 days prior to the procedure)
• 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 and/or skin directed therapy is allowed for cohort 2/expansion cohort. Systemic therapy may be initiated anytime within 4 weeks of microdevice (MD) removal. Only participants receiving systemic therapy require ongoing evaluation for assessment of clinical response
• Participants 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
• Participants 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 National Institute of Health (NIH) central data repositories
• Participant is considered to have capacity to properly follow instructions at home for the care of device(s) that will be glued and/or bandaged to the skin and fixed in place
• Participants who underwent prior MD implantation may undergo additional MD implantations in the setting of disease progression if new systemic therapy is indicated and if they meet all other inclusion criteria. Participants receiving another set of microdevices do not need to repeat germline testing (buccal swab) and will need to be re-registered

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
• Participants who will receive standard of care systemic therapy may receive new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Consistent topical steroid use (used for >= 4 weeks prior to cycle 1 day 1 [C1D1]) may be continued to all sites except those selected to undergo implantation (must undergo washout); and following retrieval may resume topical steroids to those sites - if needed as decided by treating physician
• Participants unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy who cannot safely delay therapy to allow for microdevice implantation and removal (e.g. typically 1-2 weeks) in the opinion of their treating medical or cutaneous oncology provider