ClinicalTrialsFinder
RecruitingNot ApplicableNCT04123535

Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma

Sponsor

Matthew Bucknor

Enrollment

20 participants

Start Date

Jan 23, 2020

Study Type

INTERVENTIONAL

Conditions

Undifferentiated Pleomorphic Sarcoma

Summary

This study is a single site, single-arm, feasibility study to evaluate the safety and efficacy of MRgFUS using the ExAblate 2100 System for the partial ablation of undifferentiated pleomorphic sarcomas.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Men and women \>= 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1.
  • Subjects must have either 1) a biopsy-proven new diagnosis of undifferentiated pleomorphic sarcoma (UPS) (within the last 6 months) or 2) a lesion highly suspicious for metastatic UPS based on CT or MRI imaging (within the last 6 months).
  • Target tumor \>= 2 cm in maximum diameter and \<= 20 cm in maximum diameter.
  • Target tumor accessible to the ExAblate device in the soft tissues of the chest, abdomen, pelvis, or upper or lower extremities.
  • Target tumor must be \> 1 cm from any critical structure. Critical structures are defined as skin, major nerve/vascular bundles, nerve roots, any solid organ, and any portion of the bowel.
  • Target tumor must be clearly visible by non-contrast magnetic resonance imaging (MRI)
  • For patients with newly diagnosed, not previously treated UPS, tumor must be deemed to be surgically resectable by tumor board documentation or surgeon's note.

Exclusion Criteria17

  • Note: There has never been a prospective study comparing patients receiving chemotherapy to those not receiving chemotherapy in the neoadjuvant setting for soft tissue sarcoma. Our local institutional standard is to treat patients with neoadjuvant chemotherapy prior to surgical resection when tumors are \> 5 cm in maximal dimension and within deep muscular compartments. Our institutional standard is to treat patients with doxorubicin plus ifosfamide for younger patients (typically \<50 years old) and gemcitabine plus taxotere for older patients (typically \>= 50 years old).
  • Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) treatment date.
  • History of interstitial lung disease or other active malignancy (may confound immune response results).
  • History of previous malignancies (except non-melanoma skin cancers) (may confound immune response results).
  • All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline.
  • Subjects must have recovered from the effects of major surgery or significant trauma at least 14 days before the study procedure.
  • Subjects with an acute medical condition expected to hinder them from completing the study, unstable cardiovascular status, and severe cerebrovascular disease.
  • Treatment with any investigational agent within 28 days of the treatment procedure.
  • Any absolute contraindications for study magnetic resonance imaging (MRI) per standard University of California, San Francisco (UCSF) departmental MRI safety guidance (https://radiology.ucsf.edu/patient-care/patient-safety/mri) and additionally:
  • Metal in other parts of body that will cause safety issues
  • Claustrophobia
  • Weight \> 400 pounds (lb) or 181.4 kilograms (kg).
  • Pregnancy
  • Known intolerance or allergy to magnetic resonance (MR) contrast agent (gadolinium chelates)
  • Unable to safely receive anesthesia/sedation for the treatment, or known intolerance or allergy to medications used for sedation/anesthesia.
  • Unable to verbally communicate with the investigator and staff.
  • For Group 1 Patients (newly diagnosed disease) only: Have received neoadjuvant radiotherapy or planning to receive neoadjuvant radiotherapy.

Interventions

DEVICEExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)

The ExAblate 2100 MRgFUS system (InSightec, Inc., Dallas, Texas, USA) is a noninvasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.14-16 The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 3T Magnetic Resonance (MR) scanner. The ExAblate systems provide a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control. The ExAblate transducer device is an integrated component of the MR table

Locations(1)

University of California, San Francisco

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04123535

Related Trials

Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas

NCT0405522016 locations

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

NCT043328747 locations

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

NCT0518216410 locations

MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma

NCT062771541 location

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

NCT059617614 locations