In Situ Drug Screening Microdevice for Lymphoma

Overseen By Cecilia Larocca, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Topical steroids, Radiation, Phototherapy

Disqualifiers: Pregnancy, Bleeding disorder, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a tiny implantable device (microdevice) that can release up to 19 different cancer drugs directly into skin cancer lesions. The trial focuses on cutaneous T-cell lymphoma and peripheral T-cell lymphoma, aiming to identify which approved drugs are most effective against these cancers. It suits individuals diagnosed with these types of lymphoma who have noticeable skin lesions and plan to begin systemic therapy as part of their usual care. Participants must be prepared for a skin biopsy and manage a device attached with a thin wire at home. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could enhance current care plans.

Do I need to stop my current medications for the trial?

Yes, you will need to stop certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) required, such as 2 weeks for some topical therapies and 15 weeks for certain immunotherapies. You cannot be on any systemic therapy at the time of implantation.

What prior data suggests that this microdevice is safe for use in lymphoma patients?

Research shows that the small device under study is designed to safely place and remove up to 19 drugs directly into cancerous skin areas. This method tests how different approved cancer drugs work against certain types of lymphoma, specifically cutaneous T cell lymphoma and peripheral T cell lymphoma.

Previous patients have generally tolerated the device well. The main focus has been on ensuring the device can be safely placed and removed from the skin without causing major issues. So far, reports suggest that side effects are minimal and mostly involve mild discomfort where the device is implanted.

Researchers continue to study this device to fully understand its safety and effectiveness. However, current findings are encouraging and suggest it is a promising tool for evaluating drug treatments in a targeted way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel approach to treating cutaneous T-cell lymphoma and peripheral T-cell lymphoma by using in situ drug screening microdevices. Unlike traditional treatments, which typically involve systemic therapies like chemotherapy or targeted drugs, this method allows for localized testing of multiple drugs directly within the skin lesions. This innovative delivery method could potentially identify the most effective treatment for each patient more quickly and with less systemic exposure, paving the way for personalized therapy. By directly applying the microdevices to the skin lesions, researchers hope to gather valuable data on drug responses, optimizing treatment plans and enhancing patient outcomes.

What evidence suggests that this microdevice is effective for evaluating cancer drugs against lymphoma?

Research shows that tiny devices can test how different cancer drugs work directly on skin spots in T-cell lymphoma. In this trial, participants will undergo percutaneous placement of microdevices into skin lesions. These devices release various approved cancer drugs into the spot to identify which drugs might work best. Early results suggest this method could offer a personalized treatment approach by revealing how a patient's cancer reacts to different drugs. While the study primarily examines safety and practicality, it aims to provide doctors with more information to customize treatment for each person. ^{1 2 3 5 6}

Who Is on the Research Team?

Cecilia Larocca, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My skin cancer doctor says I'm fit for minor surgery.

absolute neutrophil count ≥500/mcL

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

Exclusion Criteria

I have a bleeding or clotting issue that makes surgery risky.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdevice Placement and Retrieval

Participants undergo percutaneous placement of microdevices into skin lesions and subsequent retrieval for analysis

2 years

Standard of Care Therapy

Participants receive standard of care therapy as determined by their treating oncologist or dermatologist

Follow-up

Participants are monitored for safety and effectiveness after microdevice placement and retrieval

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Microdevices

Trial Overview 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.

How Is the Trial Designed?

Group I: Initial Cohort Experimental Treatment 2 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 Cohort Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Using a novel microfluidic platform, researchers tested combinations of three chemotherapy drugs (Paclitaxel, Vinorelbine, and Etoposide) on lung tumor spheroids, showing that combination therapies can yield better results with lower side effects compared to single-drug treatments.

The study demonstrated that low dose metronomic (LDM) chemotherapy, which uses drug combinations below the maximum tolerated dose, can potentially reduce toxicity while improving treatment outcomes, paving the way for personalized cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel design of microfluidic platform for metronomic combinatorial chemotherapy drug screening based on 3D tumor spheroid model. Sankar, S., Mehta, V., Ravi, S., et al.[2021]

The study demonstrated that a novel implantable microdevice (IMD) can be safely implanted and retrieved in patients with non-small cell lung cancer (NSCLC) during surgery, with a 93% retrieval success rate and no severe adverse reactions reported.

The IMD allows for localized delivery of multiple chemotherapeutic agents, showing differential tumor responses to the drugs, which could help tailor personalized treatment regimens based on individual tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Tsai, LL., Phillips, WW., Hung, YP., et al.[2023]

A new microfluidic platform has been developed for testing cancer treatments using intact tumor slices, which preserves the tumor's microenvironment and allows for more accurate drug response assessments.

This platform enables rapid, multiplexed drug testing, making it a promising tool for precision oncology by potentially guiding personalized therapy decisions based on real-time responses from patient-derived tumor samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microfluidic platform for functional testing of cancer drugs on intact tumor slices. Rodriguez, AD., Horowitz, LF., Castro, K., et al.[2021]

Microfluidic devices, known as 'tumor-on-chips', are emerging as effective and cost-efficient alternatives to traditional animal models for preclinical anticancer drug screening, showing promise in predicting human clinical outcomes.

Recent advancements in these microfluidic technologies address key challenges in cancer treatment, such as drug resistance and personalized medicine, suggesting they could significantly enhance the drug development process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-chip anticancer drug screening - Recent progress in microfluidic platforms to address challenges in chemotherapy. Dhiman, N., Kingshott, P., Sumer, H., et al.[2019]

A new microfluidic device was developed for drug screening that allows for simultaneous testing of four conditions and creates a concentration gradient, which can speed up the evaluation of potential drug candidates.

Using this device, researchers tested the effects of doxorubicin on breast cancer cells, demonstrating its ability to assess cell viability in dynamic conditions while allowing for the recovery and further analysis of the cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modular, reversible sealing, and reusable microfluidic device for drug screening. Vit, FF., Nunes, R., Wu, YT., et al.[2021]

A new microfabricated platform using dielectrophoresis (DEP) allows for real-time analysis of cancer drug effects on individual cells, which is more effective than traditional static assays.

This technology is particularly useful for studying hematopoietic tumor cells, as it enables dynamic monitoring of cell responses to drugs, improving the assessment of anticancer drug efficacy in challenging patient-derived samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic analysis of drug-induced cytotoxicity using chip-based dielectrophoretic cell immobilization technology. Khoshmanesh, K., Akagi, J., Nahavandi, S., et al.[2022]

A new minimally invasive method for implanting and retrieving microdevices in tumors has been successfully demonstrated, allowing for personalized assessment of cancer drug responses in live models, with no complications reported during the process.

The method showed high success rates in retrieving drug delivery sites, with a correlation between drug delivery and cancer cell death, indicating its potential efficacy for optimizing cancer treatments without the need for surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interventional image-guided microdevice implantation and retrieval method for in-vivo drug response assessment. Bhagavatula, SK., Upadhyaya, K., Miller, BJ., et al.[2020]

Microfluidic systems and organ-on-a-chip technologies can significantly enhance the study of hematologic cancers by providing patient-specific models that mimic tumor microenvironments, which is crucial for personalized treatment development.

The integration of microfluidics with machine learning and automation could revolutionize drug discovery for hematologic cancers, potentially leading to more effective therapies and improved clinical trial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications. Chowdury, MA., Heileman, KL., Moore, TA., et al.[2020]

Microphysiological Systems, or Tissue Chips, are advanced bioengineered models that better predict drug safety and efficacy compared to traditional 2-D cell cultures and animal models, addressing the high failure rates in clinical trials.

These tissue chips mimic real organ functions and can be used in various research areas, including precision medicine and toxicology, highlighting their versatility and potential to improve drug development outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NIH microphysiological systems program: developing in vitro tools for safety and efficacy in drug development. Tagle, DA.[2020]

A new method using micropatterned array chips allows for the creation of highly biomimetic three-dimensional (3D) tumor models, which are crucial for effective antitumor drug screening and cancer research.

These 3D tumor models can mimic complex tumor environments, enabling researchers to study how tumors respond to chemotherapy, which is essential for understanding drug susceptibility and resistance in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facile construction of a 3D tumor model with multiple biomimetic characteristics using a micropatterned chip for large-scale chemotherapy investigation. Sun, M., Zhang, J., Fu, W., et al.[2023]

Traditional drug safety assessments often miss complications in humans, particularly with immunotherapies, due to differences in immune responses between species and limitations of rodent models.

Organ-on-Chip models, which use human cells to recreate tissue environments, provide a promising new method to evaluate the safety of T cell-bispecific antibodies, offering better insights into their effects and potential adverse events in human tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profiling of Tumor-targeted T Cell-Bispecific Antibodies with Alveolus Lung- and Colon-on-Chip. Kerns, JS., Belgur, C., Kanellias, M., et al.[2023]

The new 3D culture microtechnology allows for the high-throughput production of tumor spheroids, which can be used for effective screening of anti-cancer drugs, facilitating the study of drug effects in a more physiologically relevant environment.

Spheroids produced using this method show normal growth and a dose-dependent decrease in viability when treated with drugs, but they exhibit greater resistance to treatments compared to traditional monolayer cultures, highlighting the importance of using 3D models in cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Throughput, Polymeric Aqueous Two-Phase Printing of Tumor Spheroids. Atefi, E., Lemmo, S., Fyffe, D., et al.[2020]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-01025

Microdevice for In Situ Candidate Drug Screening in Skin ... This pilot trial studies the side effects and feasibility of microdevice for in situ candidate drug screening in skin lesions of T-cell lymphoma.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04045470

A Pilot of a Microdevice For In Situ Candidate Drug ... 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 ...

3. withpower.com withpower.com/trial/phase-lymphoma-t-cell-peripheral-11-2019-46f62

In Situ Drug Screening Microdevice for Lymphoma What data supports the effectiveness of the treatment Microdevices for lymphoma? Research shows that microdevices can help test how different cancer drugs work ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04045470?term=AREA%5BConditionSearch%5D(%22Lymphoma,%20T-Cell,%20Cutaneous%22)%20AND%20AREA%5BBasicSearch%5D(gene%20therapy)&rank=4

A Pilot of a Microdevice For In Situ Candidate Drug Screening ... Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04045470/a-pilot-of-a-microdevice-for-in-situ-candidate-drug-screening-in-cutaneous-lesions-of-t-cell-lymphoma?mp=uro&id=52&slug=cutaneous-t-cell-lymphoma

A Pilot of a Microdevice For In Situ Candidate Drug ... This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a ...

6. dana-farber.org dana-farber.org/clinical-trials/18-639

A Pilot of a Microdevice For In Situ Candidate Drug ... 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.