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CIVO Intratumoral Microdosing of Anti-Cancer Therapies (Phase 0)

In this study, we want to learn more about the effects of different anti-cancer therapies by intramural administration. This study is for people with head and neck cancer or soft tissue sarcoma who are planning to have surgery to remove their tumor.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

At your first visit you will be screened for the study. A few days before your surgery, your tumor will be injected with a very small dose of novel cancer treatments. When the tumor is removed at your surgery, the part that was injected will be given to the research team to study how well the new treatments work. After your surgery the research team will call you to make sure you are feeling okay and they may be present at follow-up appointments with your surgeon or oncologists.

Incentives

Information provided upon request

In-person visits:
All visits

Total length of participation:
28 days

Looking for Specific Volunteers

Able to participate:

Diagnosis of HNSCC or STS
At least one tumor that is planned for surgical intervention
Ability to comply with study's visit and schedule

Not eligible if:

Patients who have received chemotherapy, radiation therapy, or hormone therapy intended to shrink the tumor prior to surgery in the past 6 months
Female patients who are lactating, breastfeeding, or have a positive pregnancy test
Patients with a diagnosis of immunodeficiency

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Emmie Cole
emmie_cole@med.unc.edu

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast, Head and Neck, Melanoma, Sarcoma (bone and soft tissue), Phase 1 Trials (all cancers), Lymphoma)

IRB Number

22-2514

ClinicalTrials.gov

NCT04541108

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Questions?

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