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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04045470
Status
Recruiting
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Conditions

  • Cutaneous T Cell Lymphoma
  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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
  • 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.

Study Details

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

Key Dates

Start date
Dec 11, 2019
Status verified
Oct 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Initial Cohort
    * 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)
  • Experimental: Expansion Cohort
    * 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

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115
Cecilia Larocca, MD
[email protected]
617-632-6571
Cecilia Larocca, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MA

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