M.D. Anderson Cancer Center
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.
Metastatic Sarcoma
Recurrent Sarcoma
Resectable Sarcoma
Doxorubicin
Doxorubicin Hydrochloride
Drug Delivery Microdevice
Everolimus
Ganitumab
Ifosfamide
Irinotecan
Pazopanib
Polyethylene Glycol
Temozolomide
Temsirolimus
Therapeutic Conventional Surgery
Vincristine
EARLY_PHASE1
PRIMARY OBJECTIVES: I. Assess the safety of drug delivery microdevice (microdevice) placement and removal in subjects undergoing resection of sarcoma. II. Determine the technical feasibility of microdevice placement and removal with intact surrounding tissue in subjects undergoing resection of a sarcoma. SECONDARY OBJECTIVE: I. Use the intratumoral cellular response to evaluate individual agents and/or drug combinations released from the microdevice reservoirs to assess the relative drug efficacy across all individual agents or drug combinations tested using the microdevice technology. EXPLORATORY OBJECTIVES: I. Evaluate the microdevice performance for its capacity to predict Response Evaluation Criteria in Solid Tumors (RECIST) response in the subset of patients that receive systemic chemotherapies as part of their standard-of-care or clinical trial treatments. II. Determine genomic, transcriptomic, and proteomic predictive biomarkers from resected specimens that correlate with local (i.e. microdevice-based) and systemic drug response. III. Determine, at a single-cell level, proteomic traits associated with chemosensitivity versus (vs.) resistance using mathematical notions of network robustness and fragility. OUTLINE: 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. Conditions Conditions: Metastatic Sarcoma Recurrent Sarcoma
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 20 participants |
| Masking : | NONE |
| Primary Purpose : | OTHER |
| Official Title : | Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas |
| Actual Study Start Date : | 2025-01-31 |
| Estimated Primary Completion Date : | 2025-12-31 |
| Estimated Study Completion Date : | 2025-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 10 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030