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

NCT04045470 | Recruiting DMC FDA Device

• 1 other identifier: 18-639
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cutaneous T Cell Lymphoma; Peripheral T Cell Lymphoma

Keywords

Cutaneous T Cell Lymphoma; Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (5)

• Local Intralesional Response To Clinically Relevant Cancer Agents In Cutaneous T Cell Lymphomas

  2 years

• Intralesional Heterogeneity In Drug Response Using Quantitative Histopathologic Assessment Of Tumor Tissue

  2 years

• Assessment Of Microdevice-Predicted Tumor Response To Drug

  3 years

• Quantitative Assessment Of Drug Effect On The Tumor Microenvironment And Signal Pathways By Immunofluorescence

  5 years

• To Identify Genomic And Transcriptomic Biomarkers of Drug Response by Whole Exome and RNA Sequencing and Subsequent Correlations To Microdevice Predicted Tumor Response

  5 years

Study Arms (2)

Initial Cohort

EXPERIMENTAL

* Patients with plaque or tumor skin lesions of cutaneous T cell lymphoma or peripheral T cell lymphoma * Mandatory skin biopsy for corollary studies will be obtained * Patients will undergo percutaneous placement of four total microdevice(s) into two skin lesions (2 MD per skin lesion)

Device: Microdevices; Other: Standard of care therapy

Expansion Cohort

EXPERIMENTAL

* Only patients with plaque or tumor skin lesions of cutaneous T cell lymphoma or peripheral T cell lymphoma who plan to start systemic therapy as part of standard of care * Mandatory skin biopsy for corollary studies will be obtained * Patients will undergo percutaneous placement of four total microdevice(s) into two skin lesions (2 MD per skin lesion) * Participants will receive standard of care therapy and clinical course followed * Participants will undergo standard of care therapy as previously determined by treating oncologist and/or dermatologist prior to enrollment to study * Participants will not be assigned any treatment intervention

Device: Microdevices; Other: Standard of care systemic therapy

Interventions

Microdevices DEVICE

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.

Expansion Cohort; Initial Cohort

Standard of care therapy OTHER

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

Initial Cohort

Standard of care systemic therapy OTHER

Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy.

Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• week from topical therapies of lesional skin selected for implantation
• weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed)
• weeks from phototherapy
• half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy
• weeks from local radiation therapy of lesional skin selected for implantation
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Cecilia Larocca, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Larocca, MD

CONTACT

617-632-6571; clarocca@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Expansion cohort may enroll only after initial cohort has completed enrollment

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 5, 2019
• Study Start: December 11, 2019
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)