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Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199026
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Sarcoma Recurrent Sarcoma Resectable Sarcoma 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 Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas
Estimated Study Start Date : January 31, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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.
Drug: Doxorubicin
Given via microdevice
Other Names:
  • Adriablastin
  • Hydroxydaunomycin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin

Drug: Doxorubicin Hydrochloride
Given via microdevice
Other Names:
  • 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
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Device: Drug Delivery Microdevice
Undergo percutaneous implantation of drug delivery microdevice
Other Name: Microdevice

Drug: Everolimus
Given via microdevice
Other Names:
  • 42-O-(2-Hydroxy)ethyl Rapamycin
  • Afinitor
  • Certican
  • RAD 001
  • RAD001
  • Votubia
  • Zortress

Biological: Ganitumab
Given via microdevice
Other Names:
  • AMG 479
  • Anti-IGF-1R Human Monoclonal Antibody AMG-479

Drug: Ifosfamide
Given via microdevice
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Drug: Irinotecan
Given via microdevice

Drug: Pazopanib
Given via microdevice
Other Name: GW786034

Drug: Polyethylene Glycol
Given via microdevice
Other Names:
  • Glycol, polyethylene
  • PEG
  • Poly(oxyethylene)
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • Polyethylene Oxide

Drug: Temozolomide
Given via microdevice
Other Names:
  • 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
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac
  • TMZ

Drug: Temsirolimus
Given via microdevice
Other Names:
  • CCI-779
  • CCI-779 Rapamycin Analog
  • Cell Cycle Inhibitor 779
  • Rapamycin Analog
  • Rapamycin Analog CCI-779
  • Torisel

Procedure: Therapeutic Conventional Surgery
Undergo standard of care surgery

Drug: Vincristine
Given via microdevice
Other Names:
  • LEUROCRISTINE
  • VCR
  • Vincrystine




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199026


Contacts
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Contact: Joseph A Ludwig 713-792-3626 jaludwig@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Joseph A. Ludwig    713-792-3626      
Principal Investigator: Joseph A. Ludwig         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joseph A Ludwig M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04199026    
Other Study ID Numbers: 2019-0171
NCI-2019-05820 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0171 ( Other Identifier: M D Anderson Cancer Center )
R01CA180279 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Doxorubicin
Liposomal doxorubicin
Daunorubicin
Irinotecan
Vincristine
Everolimus
Temozolomide
Ifosfamide
Isophosphamide mustard
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating