NCT04045470 · Dana-Farber Cancer Institute
A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma
What this study 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
View original scientific description
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
Interventions
DEVICE
Microdevices
The microdevice was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer.
OTHER
Standard of care therapy
Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy
OTHER
Standard of care systemic therapy
Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy.
Primary outcome measures
To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal
Time frame: 2 years
"Failure" will be considered any of the following: 1. Any grade 3 or 4 adverse events associated with device placement or retrieval 2. Any device resulting in "major" adverse events as listed below: * device unable to be found or unable to be retrieved * device invading into vessel or device embolism * infection or severe tissue damage or abnormal wound healing associated with device or procedure (as deemed by a neutral consultant e.g. dermatologist, ID specialist or surgeon) * severe allergic/hypersensitivity reaction * severe bleeding 3. Any device resulting in \*two or more\* "minor" adverse events as listed below: * device migration more than 10 mm * device fracture not causing a major adverse event * mild allergic/hypersensitivity reaction * manageable pain associated with biopsy procedure * minor bleeding For purposes of this endpoint, safety will be evaluated on a per-patient level, where an event is defined as any "failure" observed among all implanted devices.
To Retrieve The Device With Sufficient Tissue Of Sufficient Quality
Time frame: 2 years
For the feasibility endpoint, a "successful" procedure will be defined as the ability to retrieve the device (by either skin punch biopsy tool or surgical excision) without damaging tumor tissue surrounding the microdevice to allow for immunohistochemistry analysis. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each device considered relatively independent in terms of placement, retrieval, and analysis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations