Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
NCT ID: NCT04199026
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-02-25
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
Doxorubicin
Given via microdevice
Doxorubicin Hydrochloride
Given via microdevice
Drug Delivery Microdevice
Undergo percutaneous implantation of drug delivery microdevice
Everolimus
Given via microdevice
Ganitumab
Given via microdevice
Ifosfamide
Given via microdevice
Irinotecan
Given via microdevice
Pazopanib
Given via microdevice
Polyethylene Glycol
Given via microdevice
Temozolomide
Given via microdevice
Temsirolimus
Given via microdevice
Therapeutic Conventional Surgery
Undergo standard of care surgery
Vincristine
Given via microdevice
Interventions
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Doxorubicin
Given via microdevice
Doxorubicin Hydrochloride
Given via microdevice
Drug Delivery Microdevice
Undergo percutaneous implantation of drug delivery microdevice
Everolimus
Given via microdevice
Ganitumab
Given via microdevice
Ifosfamide
Given via microdevice
Irinotecan
Given via microdevice
Pazopanib
Given via microdevice
Polyethylene Glycol
Given via microdevice
Temozolomide
Given via microdevice
Temsirolimus
Given via microdevice
Therapeutic Conventional Surgery
Undergo standard of care surgery
Vincristine
Given via microdevice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
10 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joseph Ludwig, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-05820
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0171
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0171
Identifier Type: -
Identifier Source: org_study_id
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