Actively Recruiting
A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma
Led by Dana-Farber Cancer Institute · Updated on 2024-10-08
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new microdevice designed to release up to 19 different cancer drugs directly into skin lesions caused by cutaneous T cell lymphoma CTCL or peripheral T cell lymphoma PTCL. This pilot and feasibility study aims to evaluate the safety of inserting and removing the microdevice within cancerous lesions and to assess how the device may help identify effective drugs for treating these lymphomas. The FDA has approved all the drugs used in the device, though not specifically for these lymphomas or the microdevice itself. Participants will have up to four microdevices placed percutaneously into two skin lesions, with two devices per lesion. Some patients will also receive standard systemic therapy as determined by their oncologist or dermatologist. Patients in the expansion cohort will receive this standard therapy while their clinical progress is followed. The microdevices release very small doses of drugs directly to the tumor tissue, and after removal, tumor response to the drugs will be analyzed. During the study, participants will undergo skin biopsies and laboratory tests before device placement. Researchers will monitor for any adverse events related to the microdevice over two years and will analyze the quality of tissue retrieved with the device. The study will also evaluate drug responses within the tumor and examine molecular markers using advanced genetic and histological methods over several years. Participation includes follow-ups to assess safety and tumor reactions, with the total follow-up lasting up to five years.
CONDITIONS
Brief Title
A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of cutaneous or peripheral T-cell lymphoma with skin involvement confirmed by skin lesion evaluation
- Measurable cutaneous disease based on the modified Severity Weighted Assessment Tool (mSWAT)
- At least two skin lesions suitable for multiple device placement, each with a minimum diameter of 1.5 cm
- Completed required washout periods from prior treatments and not currently on systemic therapy at device implantation
- Minimum age of 18 years
- ECOG performance status of 2 or less (Karnofsky score 60% or higher)
- Adequate marrow function with absolute neutrophil count >= 500/mcL and platelets >= 50,000/mcL
- Evaluated by dermatologist or oncologist to determine appropriate treatment strategy
- Medically stable for percutaneous procedures
- Ability and willingness to sign informed consent
- Willingness to undergo genetic and transcriptomic sequencing and data sharing
- Ability to care for device(s) with attached guidewire at home
You will not qualify if you...
- Positive pregnancy test at screening
- Uncorrectable bleeding or blood clotting disorders increasing surgical risk
- History of allergic reactions to similar compounds used in the study
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Patients starting new skin-directed therapies concurrently with first systemic therapy after device implantation
- Inability to complete required treatment washout due to rapidly progressing disease needing immediate systemic therapy
Research Team
C
Cecilia Larocca, MD
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