Implantable microdevice delivers drugs to treat metastatic or recurrent sarcoma
Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
NA · M.D. Anderson Cancer Center · NCT04199026
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | ganitumab, doxorubicin |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04199026 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 10 years and older with biopsy-confirmed recurrent or metastatic sarcoma who are eligible for surgical resection.
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.
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 performed: While localized drug delivery approaches have been explored, this specific microdevice technology is novel and has not been widely tested in similar contexts.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Sarcoma, Recurrent Sarcoma, Resectable Sarcoma