Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
August 7, 2026 updated by: M.D. Anderson Cancer Center
Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph A Ludwig, MD
- Phone Number: 713-792-3626
- Email: jaludwig@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Principal Investigator:
- Joseph A. Ludwig
-
Contact:
- Joseph A. Ludwig
- Phone Number: 713-792-3626
- Email: jaludwig@mdanderson.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Undergo standard of care surgery
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Undergo percutaneous implantation of drug delivery microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Other Names:
Given via microdevice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.
Time Frame: Up to 1 year
|
Assess the safety of microdevice placement and removal in subjects undergoing resection of sarcoma.
|
Up to 1 year
|
|
To assess efficacy across all individual agents or drug combinations tested using the microdevice technology.
Time Frame: Up to 1 year
|
The primary outcome measure is the number of participants that experience a grade 3 or 4 adverse event, as defined by CTCAE 5.0.
A second primary outcome measure of device technical feasibility measures the number of devices that successfully generate high-quality data from each of at least 50% of the patients enrolled.
A successful device is one that generated high-quality data from at least 40% of the drugs in the device by IHC and/or other methodologies
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
Time Frame: Up to 1 year
|
The degree of cell apoptosis and cell proliferation observed in the adjacent tumor tissues will be compared for the placebo control (i.e.
PEG) to gauge the antineoplastic effect elicited by each of the drug micro-doses released by the respective microdevice reservoirs.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Ludwig, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
September 13, 2019
First Submitted That Met QC Criteria
December 12, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 7, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Connective and Soft Tissue
- Sarcoma
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Azoles
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Camptothecin
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glycosides
- Dacarbazine
- Triazenes
- Imidazoles
- Indoles
- Polymers
- Macromolecular Substances
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Alcohols
- Glycols
- Macrolides
- Lactones
- Phosphoramide Mustards
- Nitrogen Mustard Compounds
- Mustard Compounds
- Hydrocarbons, Halogenated
- Phosphoramides
- Organophosphorus Compounds
- Vinca Alkaloids
- Secologanin Tryptamine Alkaloids
- Indole Alkaloids
- Indolizidines
- Indolizines
- Anthracyclines
- Naphthacenes
- Aminoglycosides
- Daunorubicin
- Oxazines
- Cyclophosphamide
- Ethylene Glycols
- Temozolomide
- Irinotecan
- Everolimus
- Sirolimus
- Doxorubicin
- Vincristine
- Ifosfamide
- temsirolimus
- pazopanib
- Polyethylene Glycols
- ganitumab
- polyethylene glycol 400
- polyethylene glycol 8000
Other Study ID Numbers
- 2019-0171 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-05820 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA180279 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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