Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma

NCT06782399 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-379
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC).

Conditions

Squamous Cell Carcinoma of the Skin; Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Skin; Implantable Microdevice

Outcome Measures

Primary Outcomes (2)

• Feasibility of analysis

  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, and with a rim of tissue of at least 500um thickness surrounding the microdevice, to allow for downstream immunohistochemistry analysis. At least 80% of the device reservoirs need to be surrounded by tissue in order to be considered successful. 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.

  through study completion, an average of 1 year

• Cell death index measurement

  To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment. To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment. To identify which microdosed targeted or chemotherapeutic cancer agents, delivered by an implantable microdevice in cutaneous lesions of squamous cell carcinoma in the expansion cohort, induce a cell death index value of at least 30% based on quantitative histopathologic assessment.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Safety

  through study completion, an average of 1 year

• Correlation between tumor-drug response on microdevice and clinical response to systemic treatment

  through study completion, an average of 1 year

• Additional biomarker identification

  through study completion, an average of 1 year

• Intralesional heterogeneity assessment

  through study completion, an average of 1 year

Study Arms (2)

Local treatment cohort

EXPERIMENTAL

Local Treatment Cohort (5 participants) may recruit participants who plan to receive local surgical intervention (Mohs surgery or local excision) alone or in combination with further surgical treatment, radiation, or systemic therapy.

Combination Product: Microdevice

Systemic treatment cohort

EXPERIMENTAL

Systemic Treatment Cohort (20 patients) will not enroll until initial cohort has been completed (MD have been implanted, retrieved, and processed for immunohistochemical analysis). Microdevice protocol will be optimized given results derived from the local treatment cohort. Will include participants who plan to receive systemic therapy in the absence of additional local therapy (surgery or radiation). If patients receive systemic therapy, and there is clinical cutaneous residual disease after 12 weeks of systemic therapy, an additional 1 to 4 MDs will be implanted into residual cutaneous disease at this time.

Combination Product: Microdevice

Interventions

Microdevice COMBINATION_PRODUCT

Device: Microdevices The microdevice is an investigational miniaturized implantable nanodose drug delivery device. It 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. The microdevice releases nanodoses of several approved drugs into the tumor, and is then excised minimally invasively several days later. 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

Local treatment cohort; Systemic treatment 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 squamous cell carcinoma or metastatic squamous cell carcinoma with cutaneous involvement supported by histological evaluation of skin lesions based upon available clinical data including pathology reports from non-study institution (if applicable)
• Participants must have visible cutaneous disease. Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• A single lesion is amenable to placement of one or multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum lesion diameter of 1.0 cm).
• Washout period from previous treatments is not necessary.
• Age minimum of age 18. Because of limited incidence of cutaneous squamous cell carcinoma in the pediatric population, children are excluded from this study.
• 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
• Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the efficacy assessment of the systemic regimen are eligible for this trial in the systemic treatment cohort (expansion cohort).
• 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 expansion/systemic treatment cohort. 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.

You may not qualify if:

• Positive serum pregnancy test at screening visit. Pregnant women are excluded from this study because the agents used for microdosing have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is enrolled in this study.
• 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 in expansion cohort are not allowed to start any new skin directed therapy (e.g. topical 5-fluorouracil, imiquimod, etc.) 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 if desired.

Sponsors & Collaborators

• Oliver Jonas: lead
• Dana-Farber Cancer Institute: collaborator

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Central Study Contacts

Cecilia Larocca, MD

CONTACT

(617) 632-6571; clarocca@partners.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu