Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Who is this study for? Patients with Sarcoma
What treatments are being studied? Doxorubicin+Doxorubicin Hydrochloride+Drug Delivery Microdevice+Everolimus+Ganitumab+Ifosfamide+Irinotecan+Pazopanib+Polyethylene Glycol+Temozolomide+Temsirolimus+Therapeutic Conventional Surgery+Vincristine
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological, Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Joseph A Ludwig, MD
jaludwig@mdanderson.org
713-792-3626
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Device Feasibility (microdevice, surgery)
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.
Authors
Joseph A Ludwig
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov