Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472661
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Pilot Evaluation of Focused Ultrasound Ablation and Intratumoral PolyICLC in Patients With Regionally Advanced Resectable Melanoma Who Are Receiving Neoadjuvant Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mel 70
Brief Summary:
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer All participants in this study will receive an experimental treatment made up of focused ultrasound ablation FUSA a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue and an injection in the tumor with an experimental drug that activates the immune system called polyICLC polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine Neither the drug nor the device that are used in this study have been approved by the US Food and Drug Administration FDA
Detailed Description:
This study is for patients with advanced melanoma who are receiving immunotherapy and who are planning to have surgery for their melanoma cancer
The purpose of this study is to try to figure out the safety of an experimental treatment for melanoma The experimental treatment is made up of focused ultrasound ablation FUSA and an injection in the tumor intratumoral injection with an experimental drug called polyICLC polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine also known as Hiltinol that activates the immune system The researchers also want to use the results from this clinical trial to help understand how the FUSA and polyICLC affect the tumor cells at the place where the FUSA is given and how much of the surrounding tumor is affected The experimental treatment in this study is given at the University of Virginia Medical Center about three weeks before the melanoma tumor surgery that would occur as part of the participants regular care
FUSA is a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue FUSA is administered using an investigational device There are two models of the investigational device Echopulse or the Echopulse HD that will be used in the study to deliver the FUSA Both devices provide the same type of investigational treatment Participants are sedated during the FUSA procedure Up to two tumors will be treated with FUSA
The polyICLC drug will be given as a one-time injection into one tumor only after the FUSA treatment
Neither the drug nor the device that are used in this study have been proven to be safe or helpful and they are not approved by the US Food and Drug Administration FDA
This study also includes tumor elastography procedures Tumor elastography is an ultrasound picture that is taken to measure the stiffness or the flexibility of the tumor Participants in the study may be asked to have a biopsy of their tumor before starting the study intervention and will be asked participate in optional biopsies of the tumor after enrollment in the study This study includes collection of blood for research purposes optional
The purpose of this study is to try to figure out the safety of an experimental treatment for melanoma The experimental treatment is made up of focused ultrasound ablation FUSA and an injection in the tumor intratumoral injection with an experimental drug called polyICLC polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine also known as Hiltinol that activates the immune system The researchers also want to use the results from this clinical trial to help understand how the FUSA and polyICLC affect the tumor cells at the place where the FUSA is given and how much of the surrounding tumor is affected The experimental treatment in this study is given at the University of Virginia Medical Center about three weeks before the melanoma tumor surgery that would occur as part of the participants regular care
FUSA is a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue FUSA is administered using an investigational device There are two models of the investigational device Echopulse or the Echopulse HD that will be used in the study to deliver the FUSA Both devices provide the same type of investigational treatment Participants are sedated during the FUSA procedure Up to two tumors will be treated with FUSA
The polyICLC drug will be given as a one-time injection into one tumor only after the FUSA treatment
Neither the drug nor the device that are used in this study have been proven to be safe or helpful and they are not approved by the US Food and Drug Administration FDA
This study also includes tumor elastography procedures Tumor elastography is an ultrasound picture that is taken to measure the stiffness or the flexibility of the tumor Participants in the study may be asked to have a biopsy of their tumor before starting the study intervention and will be asked participate in optional biopsies of the tumor after enrollment in the study This study includes collection of blood for research purposes optional
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None