20 Participants Needed

Drug Delivery Microdevice for Sarcoma

JA
JA
Overseen ByJoseph A Ludwig, MD
Age: Any Age
Sex: Any
Trial Phase: Phase < 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

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 data supports the effectiveness of this drug for treating sarcoma?

Research shows that drug delivery systems, including microdevices, have significantly improved cancer treatments by allowing controlled and localized delivery of drugs, which can enhance their effectiveness and reduce side effects. Additionally, studies indicate that delivering cancer drugs directly into tumors can help determine their effectiveness, potentially improving patient outcomes.12345

Is the Drug Delivery Microdevice for Sarcoma generally safe for humans?

The reviewed research suggests that new drug delivery methods, like the Drug Delivery Microdevice, aim to reduce toxicity by targeting drugs directly to tumors, minimizing side effects. These methods are being explored to improve safety and effectiveness in treating sarcomas.678910

How does the Drug Delivery Microdevice treatment for sarcoma differ from other treatments?

The Drug Delivery Microdevice for sarcoma is unique because it allows for localized delivery of drugs directly to the tumor site, minimizing systemic side effects and improving drug effectiveness. This approach contrasts with traditional systemic chemotherapy, which can have widespread side effects and limited tumor penetration.511121314

Research Team

JL

Joseph A. Ludwig

Principal Investigator

The University of Texas MD Anderson Cancer Center

Eligibility Criteria

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.
See 1 more

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Drug Delivery Microdevice
  • Everolimus
  • Ganitumab
  • Ifosfamide
  • Irinotecan
  • Pazopanib
  • Polyethylene Glycol
  • Temozolomide
  • Temsirolimus
  • Vincristine
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Device Feasibility (microdevice, surgery)Experimental Treatment13 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Drug testing in the patient: toward personalized cancer treatment. [2018]
MEMS-enabled implantable drug infusion pumps for laboratory animal research, preclinical, and clinical applications. [2021]
Bridging the Translational Divide in Oncology: In Vivo Testing of Chemo-sensitivity. [2021]
Advancing the field of drug delivery: taking aim at cancer. [2019]
Clinical applications of biomedical microdevices for controlled drug delivery. [2015]
Experimental approaches to treatment of soft tissue sarcoma. [2019]
Tumor Subtype Determines Therapeutic Response to Chimeric Polypeptide Nanoparticle-based Chemotherapy in Pten-deleted Mouse Models of Sarcoma. [2023]
The role of inflammation in sarcoma. [2016]
Phase I and phase II clinical trials in sarcoma: Implications for drug discovery and development. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Novel therapeutic approaches in pediatric and young adult sarcomas. [2019]
3D printed drug-loaded implantable devices for intraoperative treatment of cancer. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
In-plane microvortices micromixer-based AC electrothermal for testing drug induced death of tumor cells. [2020]
In vivo delivery of BCNU from a MEMS device to a tumor model. [2019]
Microneedle-based delivery devices for cancer therapy: A review. [2020]