Implantable microdevice delivers drugs to treat metastatic or recurrent sarcoma
Official title: Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
Run by M.D. Anderson Cancer Center · NCT04199026 · Data updated 2026-11-12
This study is testing a tiny device that delivers small doses of cancer drugs directly to tumors in patients with metastatic or recurrent sarcoma to see if it helps improve their treatment outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | ganitumab, doxorubicin |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT04199026 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 10 years and older with biopsy-confirmed recurrent or metastatic sarcoma who are eligible for surgical resection.
✕Probably not a fit
Patients who are not candidates for surgical resection or those with allergies to the drugs used in the microdevice may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase I trial evaluates the safety and feasibility of implanting a microdevice that delivers microdoses of various drugs directly into tumor tissue in patients with metastatic or recurrent sarcoma. The microdevice, about the size of a grain of rice, is implanted prior to surgical resection and aims to assess the local effects of the drugs on tumor cells. The study also explores the cellular response to different drug combinations and seeks to identify biomarkers that predict treatment response. By focusing on localized drug delivery, the trial aims to improve treatment outcomes for patients with sarcomas.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of drug delivery in treating sarcomas while minimizing systemic side effects.
How similar studies have gone: While localized drug delivery approaches have been explored, this specific microdevice technology is novel and has not been widely tested in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion: * Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care. * 10 years of age or older * Documented, signed, dated informed consent to participate in the microdevice study * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 Exclusion: * Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection * Age \< 10 years old * Women of childbearing potential without a negative pregnancy test; or women who are lactating * Allergies or prior adverse drug reactions to any of the drugs loaded within the microdevice.
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Joseph Ludwig, MD — M.D. Anderson Cancer Center
- Study coordinator: Joseph A Ludwig, MD
- Email: jaludwig@mdanderson.org
- Phone: 713-792-3626
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Real-time imaging of tumor blood vessels during surgery
We will test whether a real-time microscope technique during surgery can show how well blood vessels in adults' solid tumors work and whether that helps predict if systemic cancer medicines can reach the tumor.
-
Impact of digital health support on symptom and side-effect management for advanced/metastatic sarcoma
A digital health platform is being tested to help adults with advanced or metastatic sarcoma manage symptoms and side effects while receiving standard cancer care.
-
Targeted radiation therapy for young patients with metastatic sarcoma
This study is testing if a special type of radiation therapy can help young patients with metastatic sarcoma live longer and have fewer health issues compared to those who don’t receive it.
-
Using 64Cu-LNTH-1363S for imaging in patients with sarcoma or gastrointestinal cancers
This study is testing a new imaging agent called 64Cu-LNTH-1363S in patients with metastatic sarcoma or gastrointestinal cancers to see how safe it is and how well it works for imaging their tumors.
-
Using Cytalux for better cancer surgery in children
This study is testing if a special imaging agent called Cytalux can help doctors find and remove lung tumors more effectively during surgery in children with cancer.
-
Testing a new combination of chemotherapy drugs for advanced sarcoma
This study is testing a new combination of chemotherapy drugs to see if it can help people with advanced sarcoma feel better and manage their disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.