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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0. [Срок оценки: Up to 1 year]
• To assess efficacy across all individual agents or drug combinations tested using the microdevice technology. [Срок оценки: Up to 1 year]

Вторичные конечные точки (1)

• Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir. [Срок оценки: Up to 1 year]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗