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
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 T-cell lymphoma or peripheral T-cell lymphoma with skin involvement confirmed by biopsy
- Measurable skin disease with at least two lesions suitable for device placement, each at least 1.5 cm in diameter
- Minimum washout periods from previous treatments: 2 weeks from topical therapies and certain drugs, 4 weeks from phototherapy, 5 half-lives from systemic cytotoxic drugs, 12 weeks from local radiation, 15 weeks from systemic immunotherapy
- Age 18 years or older
- ECOG performance status 2 or better (Karnofsky 60% or higher)
- Adequate bone marrow function with specified neutrophil and platelet counts
- Evaluation by dermatologist or oncologist to determine appropriate treatment plan
- Medically stable for percutaneous procedures
- Ability to understand and sign informed consent
- Willingness to undergo genetic and transcriptomic sequencing and data sharing
- Ability to properly care for the device with attached guidewire at home
You will not qualify if you...
- Positive pregnancy test at screening
- Uncorrectable bleeding or clotting disorders increasing surgical risk
- History of allergic reactions to similar drug compounds
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting study compliance
- Starting new skin-directed therapies concurrent with first systemic therapy after device use is not allowed
- Inability to complete required treatment washout due to rapidly progressing disease requiring immediate therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
C
Cecilia Larocca, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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