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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Cecilia Larocca, MD
clarocca@partners.org
617-632-6571
Time Frame
Start Date: 2019-12-11
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov

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