A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Microdevices
DeviceThe 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.
Standard of care therapy
Other interventionParticipant 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
Standard of care systemic therapy
Other interventionParticipant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Initial CohortExperimental treatment 2 interventions
Group B: Expansion CohortExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal
"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.
Time frame
2 years2
To Retrieve The Device With Sufficient Tissue Of Sufficient Quality
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.
Time frame
2 yearsSecondary outcomes
1
Local Intralesional Response To Clinically Relevant Cancer Agents In Cutaneous T Cell Lymphomas
Time frame
2 years2
Intralesional Heterogeneity In Drug Response Using Quantitative Histopathologic Assessment Of Tumor Tissue
Comparison of tumor responses to like drug delivered from separate microdevices.
Time frame
2 years3
Assessment Of Microdevice-Predicted Tumor Response To Drug
Correlation of tumor response to drug released by microdevice compared with clinical response to systemic administration of like drug
Time frame
3 years4
Quantitative Assessment Of Drug Effect On The Tumor Microenvironment And Signal Pathways By Immunofluorescence
Descriptive statistics will be used to summarize the quantitative measurements in cell number of different immunophenotypes and quantify signal transduction cascades. Descriptive statistics will be employed to summarize the variance in different measures of drug-induced microenvironment changes across participants.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov