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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Microdevices for lymphoma?

Research shows that microdevices can help test how different cancer drugs work on tumors, which can lead to more personalized and effective treatments. These devices have been used successfully in other types of cancer to find the best drug combinations and improve treatment outcomes. ^{1 2 3 4 5}

What safety data exists for the In Situ Drug Screening Microdevice treatment?

The safety of implantable microdevices has been evaluated in a study involving patients with nonsmall cell lung cancer, where the implantation and retrieval of the device were found to be safe and feasible. ^{1 3 6 7 8}

How does the in situ drug screening microdevice for lymphoma differ from other treatments?

The in situ drug screening microdevice for lymphoma is unique because it uses a microfluidic platform to rapidly test multiple drugs on live tumor cells, allowing for personalized treatment decisions. This approach is different from traditional methods as it maintains the tumor's microenvironment and provides quicker results, which can be crucial for tailoring therapy to individual patients. ^{1 9 10 11 12}

Research Team

Cecilia Larocca, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

absolute neutrophil count ≥500/mcL

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A microfluidic platform for functional testing of cancer drugs on intact tumor slices. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A novel design of microfluidic platform for metronomic combinatorial chemotherapy drug screening based on 3D tumor spheroid model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

An interventional image-guided microdevice implantation and retrieval method for in-vivo drug response assessment. [2020]

4. England pubmed.ncbi.nlm.nih.gov

On-chip anticancer drug screening - Recent progress in microfluidic platforms to address challenges in chemotherapy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Profiling of Tumor-targeted T Cell-Bispecific Antibodies with Alveolus Lung- and Colon-on-Chip. [2023]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

High Throughput, Polymeric Aqueous Two-Phase Printing of Tumor Spheroids. [2020]

10. England 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. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A modular, reversible sealing, and reusable microfluidic device for drug screening. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Dynamic analysis of drug-induced cytotoxicity using chip-based dielectrophoretic cell immobilization technology. [2022]