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Recruiting NCT04199026

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

No phase Interventional Metastatic Sarcoma Recurrent Sarcoma Resectable Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxorubicin, Doxorubicin Hydrochloride, Drug Delivery Microdevice, Everolimus.
Who it may be relevant to
Registry conditions: Metastatic Sarcoma, Recurrent Sarcoma, Resectable Sarcoma. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

Overview

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:

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

Interventions

  • Drug Doxorubicin
    Given via microdevice
  • Drug Doxorubicin Hydrochloride
    Given via microdevice
  • Device Drug Delivery Microdevice
    Undergo percutaneous implantation of drug delivery microdevice
  • Drug Everolimus
    Given via microdevice
  • Biological Ganitumab
    Given via microdevice
  • Drug Ifosfamide
    Given via microdevice
  • Drug Irinotecan
    Given via microdevice
  • Drug Pazopanib
    Given via microdevice
  • Drug Polyethylene Glycol
    Given via microdevice
  • Drug Temozolomide
    Given via microdevice

Primary outcome measures

  • 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]
  • To assess efficacy across all individual agents or drug combinations tested using the microdevice technology. [Time frame: Up to 1 year]
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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04199026 · 2019-0171 · NCI-2019-05820 · 2019-0171 · R01CA180279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗