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

Launched by DANA-FARBER CANCER INSTITUTE · Aug 1, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat cutaneous T-cell lymphoma and peripheral T-cell lymphoma, which are types of skin cancers. Researchers want to see if a small device that can release up to 19 different cancer drugs directly into the affected skin can help evaluate how well these drugs work. The goal is to ensure the safety of placing and removing this device.

To participate, you must be at least 18 years old and have a confirmed diagnosis of one of these skin cancers with visible lesions. Your doctor will assess if your skin lesions are suitable for the study, and you must not be on certain treatments for a specified period before enrolling. If you join the trial, you will have the device implanted in your skin, and your doctor will monitor your progress. Participants will also take part in some genetic testing as part of the research. Remember, this study is currently recruiting, so if you meet the criteria and are interested, you can discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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