Drug Delivery Microdevice for Sarcoma

Overseen By Joseph A Ludwig, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: High surgical risk, Pregnancy, Lactation, others

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

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a tiny device called the Drug Delivery Microdevice, which delivers small doses of different drugs directly into sarcoma tumors. The goal is to identify which drugs most effectively impact tumor tissue in individuals with recurrent or metastatic sarcomas. Participants will have the device implanted into their tumor a few days before their scheduled surgery and removed during the procedure. This study may suit those whose sarcoma has recurred or spread and who are planning surgery as part of their treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options for sarcoma patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this microdevice is safe for patients with sarcomas?

Research shows that using a tiny device in sarcoma patients is generally well-tolerated. This device, about the size of a grain of rice, tests how different drugs affect tumor tissue. In studies, patients have not reported serious side effects from the device itself. The goal is to deliver small doses of various drugs directly into the tumor.

The device helps doctors identify which drugs might work best against the cancer without affecting the whole body. This targeted approach can reduce side effects compared to traditional treatments that spread throughout the body. While the device itself appears safe, the drugs it delivers are standard cancer treatments with known safety profiles. Doctors understand these drugs' effects and risks well.

Overall, evidence so far suggests this method is safe for patients, with any risks carefully monitored by medical professionals during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the drug delivery microdevice for sarcoma because it offers a new way to administer multiple cancer-fighting drugs directly to tumors. Unlike traditional treatments that circulate drugs throughout the entire body, this microdevice targets the tumor site more precisely, potentially reducing side effects and improving effectiveness. This targeted delivery method allows for a combination of drugs like doxorubicin, ifosfamide, and others, to be administered simultaneously, which might enhance their collective impact on the tumor. Plus, the microdevice is removable after just a few days, aligning with surgical treatments and potentially offering quicker insights into treatment effectiveness.

What evidence suggests that this microdevice is effective for sarcoma?

Research has shown that delivering cancer drugs directly into tumors can help assess their effectiveness, potentially improving outcomes for patients with sarcoma. In this trial, participants will have up to three drug delivery microdevices implanted before standard care surgery. These devices release drugs such as doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus directly into the tumor. Early evidence suggests these tiny devices can predict drug effectiveness. This method might yield results similar to traditional chemotherapy but with more focus. By using this device, doctors aim to identify which drugs best shrink or control tumors. This targeted delivery could lead to better treatment choices and improved patient care. ^{1 6 7 8 9}

Who Is on the Research Team?

Joseph A. Ludwig

Principal Investigator

The University of Texas MD Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people aged 10 or older with sarcoma that has spread or returned, and who need surgery as part of their treatment. They must be able to perform daily activities (ECOG <=2) and consent to participate. It's not for those under 10, pregnant or breastfeeding women, patients refusing surgery, or with allergies to drugs in the microdevice.

Inclusion Criteria

My sarcoma has returned or spread and surgery is recommended.

Documented, signed, dated informed consent to participate in the microdevice study

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

Exclusion Criteria

I am younger than 10 years old.

I do not want or cannot have surgery for my condition.

You are allergic to any of the drugs used in the microdevice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdevice Implantation

Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery

2 days

1 visit (in-person)

Surgery and Microdevice Removal

At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Doxorubicin
• Doxorubicin Hydrochloride
• Drug Delivery Microdevice
• Everolimus
• Ganitumab
• Ifosfamide
• Irinotecan
• Pazopanib
• Polyethylene Glycol
• Temozolomide
• Temsirolimus
• Vincristine

Trial Overview The study tests a tiny implantable device containing microdoses of various drugs like Doxorubicin and Everolimus directly into sarcoma tumors. The goal is to see which drugs affect tumor tissue when delivered through this new method during standard surgical care.

How Is the Trial Designed?

Group I: Device Feasibility (microdevice, surgery) Experimental Treatment 13 Interventions

Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A review of 238 phase I and II clinical trials for sarcomas revealed that only 5% led to phase III trials, with the majority of successful trials being funded by industry, highlighting the importance of industry support in advancing sarcoma treatments.

Most trials tested drugs not originally developed for sarcoma (about 90%) and often combined different sarcoma subtypes in studies, which may limit the understanding of drug efficacy across specific sarcoma types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and phase II clinical trials in sarcoma: Implications for drug discovery and development. Lee, DY., Staddon, AP., Shabason, JE., et al.[2021]

The study demonstrated that a chimeric polypeptide doxorubicin (CP-Dox) formulation was more effective than free doxorubicin in treating malignant peripheral nerve sheath tumors (MPNSTs), showing increased drug retention and elevated CD8+ T cell levels.

However, in undifferentiated pleomorphic sarcoma (UPS) models, CP-Dox did not improve survival compared to free doxorubicin, indicating that the effectiveness of nanoparticle-encapsulated chemotherapy can vary significantly depending on the specific tumor subtype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Subtype Determines Therapeutic Response to Chimeric Polypeptide Nanoparticle-based Chemotherapy in Pten-deleted Mouse Models of Sarcoma. Dodd, RD., Scherer, A., Huang, W., et al.[2023]

The AC electrothermal (ACET) micromixer developed in this study achieved a high mixing efficiency of 89.12% at a voltage of 3V and frequency of 500 kHz, making it effective for delivering uniform drug concentrations to tumor cells.

When tested with tamoxifen on human breast cancer cells (MCF-7) over five days, the micromixer demonstrated potential for enhancing drug delivery and promoting rapid tumor cell death, indicating its usefulness in organ-on-a-chip systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-plane microvortices micromixer-based AC electrothermal for testing drug induced death of tumor cells. Lang, Q., Ren, Y., Hobson, D., et al.[2020]

Combining new targeted therapies with conventional chemotherapy may enhance tumor-killing effects while reducing toxicity and the risk of drug resistance in sarcoma treatment.

Innovative drug delivery methods, such as metronomic scheduling and isolated limb perfusion, allow for higher concentrations of therapeutic agents to be administered directly to tumors, minimizing systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental approaches to treatment of soft tissue sarcoma. Hwang, RF., Hunt, KK.[2019]

Drug delivery systems for cancer treatments have been widely used and have improved both new and existing therapies, benefiting millions of patients.

Current systems include various methods like controlled delivery, local chemotherapy, and liposomal systems, while future innovations may involve 'smart' delivery methods like controlled release microchips.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the field of drug delivery: taking aim at cancer. Moses, MA., Brem, H., Langer, R.[2019]

Sarcomas are complex tumors that are difficult to treat, often requiring a team of specialists, and are associated with chronic inflammation, which plays a significant role in their development.

Recent advancements in targeted therapies, including the use of oncolytic viruses and anti-inflammatory nutraceuticals, show promise in interrupting key signaling pathways involved in sarcoma growth, potentially leading to less toxic treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of inflammation in sarcoma. Radons, J.[2016]

The development of miniaturized drug delivery microdevices offers new opportunities for treating both acute and chronic conditions by allowing precise control over drug release and pharmacokinetics.

These microdevices can enhance treatment adherence and effectiveness, particularly in complex clinical scenarios like cancer and hemorrhagic shock, potentially leading to improved clinical outcomes and significant social benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of biomedical microdevices for controlled drug delivery. Gurman, P., Miranda, OR., Clayton, K., et al.[2015]

Two innovative devices have been developed to deliver cancer drugs directly into tumors, which can help determine how sensitive a tumor is to specific treatments.

If these devices are used in clinical practice, they could lead to more targeted cancer therapies, improving patient survival rates while minimizing unnecessary side effects from indiscriminate drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug testing in the patient: toward personalized cancer treatment. Coombes, RC.[2018]

Innovative implantable drug delivery devices are being developed to effectively administer biologics, gene therapies, and small molecules that cannot be taken orally or through other common methods, ensuring direct delivery to the treatment site.

Recent advancements in microtechnologies have led to the creation of MEMS-enabled micropumps that can provide precise, on-demand drug delivery, showing promise in preclinical studies for applications like cancer treatment and chronic ocular dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEMS-enabled implantable drug infusion pumps for laboratory animal research, preclinical, and clinical applications. Meng, E., Hoang, T.[2021]

The study explored a new method of microinjecting multiple drugs into sarcomas to assess their pharmacodynamic responses after tumor resection, which could help evaluate the effectiveness of anticancer treatments.

This innovative approach may provide valuable insights into how well different anticancer agents work in human tumors, potentially leading to more effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Translational Divide in Oncology: In Vivo Testing of Chemo-sensitivity. Sleijfer, S., Lolkema, M.[2021]

Novel therapies in sarcoma treatment can significantly enhance quality of life and improve outcomes for high-risk patients, with various options tailored to specific types of sarcomas.

Innovative local control measures, such as embolization and thermal ablation, are crucial for effectively managing tumors and metastases, contributing to better symptom control and reduced side effects from traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel therapeutic approaches in pediatric and young adult sarcomas. Anderson, PM., Pearson, M.[2019]

A microelectromechanical systems (MEMS) device effectively delivered the chemotherapeutic agent BCNU directly to tumors in rats, showing a dose-dependent inhibition of tumor growth with doses ranging from 0.67 to 2 mg.

The MEMS device demonstrated similar effectiveness to traditional subcutaneous injections of BCNU, and its design allows for precise control over the release of multiple therapeutic agents, suggesting potential for enhanced combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo delivery of BCNU from a MEMS device to a tumor model. Li, Y., Ho Duc, HL., Tyler, B., et al.[2019]

A novel drug-loaded arrowhead array device (AAD) was developed using 3D printing technology to deliver chemotherapy directly to the surgical site, which significantly reduced local recurrence of cancer after surgery in murine models.

The AAD not only improved survival rates but also has the potential for personalization in clinical applications, enhancing the effectiveness of chemotherapy while minimizing systemic toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D printed drug-loaded implantable devices for intraoperative treatment of cancer. Hagan, CT., Bloomquist, C., Warner, S., et al.[2023]

Microneedle-based delivery systems are gaining attention for their ability to locally implant therapeutics directly into tumor tissue, which helps avoid complications associated with systemic drug delivery.

These devices can effectively deliver a range of therapeutic agents, including chemotherapeutics and vaccines, potentially enhancing the effectiveness of cancer treatments by improving drug penetration into tumor tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedle-based delivery devices for cancer therapy: A review. Moreira, AF., Rodrigues, CF., Jacinto, TA., et al.[2020]

Citations

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Study Details | NCT04199026 | Implantable Microdevice for ... The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

2. withpower.com withpower.com/trial/early-phase-1-sarcoma-4-2020-9c424

Drug Delivery Microdevice for Sarcoma Additionally, studies indicate that delivering cancer drugs directly into tumors can help determine their effectiveness, potentially improving patient outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11154327/

The Impact of Nanomedicine on Soft Tissue Sarcoma Treated ... This article presents a comprehensive review of nanoparticle-assisted treatment approaches for soft tissue sarcoma (STS).

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Intratumoral drug-releasing microdevices allow in situ high ... We found early evidence that IMD readouts of intratumor nanodose drug effect parallel the extent of tumor response observed with systemic chemotherapy in ...

5. nature.com nature.com/articles/s43246-024-00612-2

Recent advances in drug delivery systems for ... Results indicated that PLGA-LDH-MTX and PLGA-MTX NPs were both effective in suppressing tumor growth in subcutaneous mouse model compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4825177/

An implantable microdevice to perform high-throughput in ... We have developed an implantable device that can perform drug sensitivity testing of several anticancer agents simultaneously inside the living tumor.

7. cell.com cell.com/cell-stem-cell/fulltext/S1934-5909(24)00296-0

The landscape of drug sensitivity and resistance in sarcoma We leverage PDTOs to characterize the landscape of drug resistance and sensitivity in sarcoma, collecting 194 specimens from 126 patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492436/

An Interventional Radiology Method for In Situ ... To evaluate the technical feasibility and safety of a nonsurgical interventional method for placement and retrieval of implantable microdevices ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04199026/implantable-microdevice-for-the-delivery-of-drugs-and-their-effect-on-tumors-in-patients-with-metastatic-or-recurrent-sarcoma

Implantable Microdevice for the Delivery of Drugs and ... The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas. Read more ...