Metastatic SarcomaNCT04199026
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
A study testing Doxorubicin, Doxorubicin Hydrochloride and Drug Delivery Microdevice in people with Metastatic Sarcoma and Recurrent Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Metastatic Sarcoma, Recurrent Sarcoma, Resectable Sarcoma
- What is being tested?
- Doxorubicin, Doxorubicin Hydrochloride and Drug Delivery Microdevice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Joseph A. Ludwig, 713-792-3626, jaludwig@mdanderson.org
Joseph A. Ludwig
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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
- Conditions
- Metastatic Sarcoma, Recurrent Sarcoma, Resectable Sarcoma
- Being tested
- Doxorubicin, Doxorubicin Hydrochloride, Drug Delivery Microdevice, Everolimus, Ganitumab
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given via microdevice
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given via microdevice
Drug Delivery MicrodeviceDevice
Also called Microdevice
Undergo percutaneous implantation of drug delivery microdevice
EverolimusDrug
Also called 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001
Given via microdevice
GanitumabBiological
Also called AMG 479, Anti-IGF-1R Human Monoclonal Antibody AMG-479
Given via microdevice
IfosfamideDrug
Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan
Given via microdevice
IrinotecanDrug
Given via microdevice
PazopanibDrug
Also called GW786034
Given via microdevice
Polyethylene GlycolDrug
Also called Glycol, polyethylene, PEG, Poly(oxyethylene), Polyethylene Glycol 400
Given via microdevice
TemozolomideDrug
Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831
Given via microdevice
TemsirolimusDrug
Also called CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog
Given via microdevice
Therapeutic Conventional SurgeryProcedure or surgery
Undergo standard of care surgery
VincristineDrug
Also called LEUROCRISTINE, VCR, Vincrystine
Given via microdevice
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility (microdevice, surgery) | Experimental | 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. Receives: Drug: Doxorubicin; Drug: Doxorubicin Hydrochloride; Device: Drug Delivery Microdevice; Drug: Everolimus; Biological: Ganitumab; Drug: Ifosfamide; Drug: Irinotecan; Drug: Pazopanib; Drug: Polyethylene Glycol; Drug: Temozolomide; Drug: Temsirolimus; Procedure: Therapeutic Conventional Surgery; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.
Assess the safety of microdevice placement and removal in subjects undergoing resection of sarcoma.
Measured: Up to 1 year
To assess efficacy across all individual agents or drug combinations tested using the microdevice technology.
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
Measured: Up to 1 year
Secondary outcomes (1)
Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start25 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Ludwig, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199026
- Sponsor's protocol ID
- 2019-0171
- Other IDs
- NCI-2019-05820, 2019-0171, R01CA180279
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2019
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
- ClinicalTrials.gov ID
- NCT04199026
- Acronym / sponsor ID
- 2019-0171
- Conditions
- Metastatic Sarcoma, Recurrent Sarcoma, Resectable Sarcoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility (microdevice, surgery) | Experimental | Drug: Doxorubicin, Drug: Doxorubicin Hydrochloride, Device: Drug Delivery Microdevice, Drug: Everolimus, Biological: Ganitumab, Drug: Ifosfamide, Drug: Irinotecan, Drug: Pazopanib, Drug: Polyethylene Glycol, Drug: Temozolomide, Drug: Temsirolimus, Procedure: Therapeutic Conventional Surgery, Drug: VincristinePatients 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinAlso: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, HydroxyldaunorubicinGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| Doxorubicin HydrochlorideAlso: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, AdriamycinGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| Drug Delivery MicrodeviceAlso: MicrodeviceUndergo percutaneous implantation of drug delivery microdevice | Device | Device Feasibility (microdevice, surgery) |
| EverolimusAlso: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001Given via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| GanitumabAlso: AMG 479, Anti-IGF-1R Human Monoclonal Antibody AMG-479Given via microdevice | Biological | Device Feasibility (microdevice, surgery) |
| IfosfamideAlso: Asta Z 4942, Asta Z-4942, Cyfos, HoloxanGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| IrinotecanGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| PazopanibAlso: GW786034Given via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| Polyethylene GlycolAlso: Glycol, polyethylene, PEG, Poly(oxyethylene), Polyethylene Glycol 400Given via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| TemozolomideAlso: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831Given via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| TemsirolimusAlso: CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin AnalogGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
| Therapeutic Conventional SurgeryUndergo standard of care surgery | Procedure or surgery | Device Feasibility (microdevice, surgery) |
| VincristineAlso: LEUROCRISTINE, VCR, VincrystineGiven via microdevice | Drug | Device Feasibility (microdevice, surgery) |
Primary outcome
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.
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Metastatic Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingPhase 2
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, AXIOM Trial
Advanced Alveolar Soft Part Sarcoma, Advanced Soft Tissue Sarcoma
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Ludwig, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxorubicin, Doxorubicin Hydrochloride and Drug Delivery Microdevice in people with Metastatic Sarcoma and Recurrent Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph A Ludwig, MD (713-792-3626, jaludwig@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.