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In Situ Drug Screening Microdevice for Lymphoma

N/A

Recruiting

Led By Cecilia Larocca, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a microdevice that releases up to 19 drugs directly into a cancerous lesion. The goal is to see if it is safe and effective against two types of lymphoma.

Who is the study for?

Adults with cutaneous T-cell lymphoma or peripheral T-cell lymphoma and measurable skin lesions can join. They must have stopped previous treatments for specific periods, be medically stable for minor procedures, and able to care for the device at home. Pregnant individuals, those needing immediate therapy, with bleeding disorders or severe allergies to similar drugs cannot participate.Check my eligibility

What is being tested?

The trial is testing a microdevice that releases up to 19 cancer drugs directly into the tumor in the skin. It aims to see how safe it is to implant and remove this device and how effective these drugs are against certain types of lymphoma.See study design

What are the potential side effects?

Potential side effects may include reactions at the site where the microdevice is implanted, such as pain or infection. There could also be allergic reactions or side effects from any of the released drugs, which will vary depending on which drug affects an individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of lymphoma that affects my skin.

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I can take care of myself but might not be able to do active work.

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I am 18 years old or older.

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It has been 15 weeks since my last immunotherapy targeting PD-1/PD-L1.

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I agree to have my genetic information studied and shared anonymously for research.

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My recent tests show my blood cell counts are within the required range.

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I have skin lesions that can be measured for changes.

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I agree to have my genetic information studied and shared anonymously for research.

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I have been diagnosed with a type of lymphoma that affects my skin.

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I have visible skin cancer lesions that can be measured.

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I am 18 years old or older.

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It's been 12 weeks since my last skin radiation therapy where the implant will go.

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I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal

To Retrieve The Device With Sufficient Tissue Of Sufficient Quality

Secondary outcome measures

Assessment Of Microdevice-Predicted Tumor Response To Drug

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

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Initial CohortExperimental Treatment2 Interventions

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)

Group II: Expansion CohortExperimental Treatment2 Interventions

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,961 Total Patients Enrolled

Cecilia Larocca, MD5.03 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

5Patient Review

Dr. Larocca was incredibly considerate, taking care to listen to my concerns and explain the tests she was ordering. She made sure to introduce me to the other members of the care team. I appreciate how she kept checking in to make sure that all of my questions and concerns were addressed.

Media Library

Microdevices Clinical Trial Eligibility Overview. Trial Name: NCT04045470 — N/A

Cutaneous T-Cell Lymphoma Research Study Groups: Expansion Cohort, Initial Cohort

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Microdevices Highlights & Side Effects. Trial Name: NCT04045470 — N/A

Microdevices 2023 Treatment Timeline for Medical Study. Trial Name: NCT04045470 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being included in this research program?

"Affirmative. The information available on clinicaltrials.gov affirms that this experiment is actively recruiting participants, having been first published on December 11th 2019 and updated most recently on July 16th 2022. Only 20 test subjects are required from one medical centre."

Answered by AI

Is recruitment for this experiment still in progress?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently searching for candidates with an initial post date of December 11th 2019 and a most recent update on July 16th 2022. The study necessitates the recruitment of 20 patients from 1 hospital location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Cecilia Larocca, MD 2019. "A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04045470.