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

First listed
Aug 5, 2019
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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