Purpose of this Study
We are doing this study to find out if an experimental drug and device system called X-PACT is a safe and effective treatment for various forms of cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have soft tissue sarcoma, melanoma, breast cancer, or head and neck cancer
- Still have cancer after treatment with the standard therapies
- Do not have any other treatment options left
Age Range
8-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you join this study, you will:
- Be injected with the study treatment (X-PACT) five times
- Give tumor tissue
- Have physical exams, blood draws, and urine tests
- Have a heart scan (ECG)
- Have imaging scans (X-Rays, MRI and/or CT)
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection in Patients with Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma
Study Website
Principal Investigator
William
Eward
Protocol Number
PRO00105022
NCT ID
NCT04389281
Phase
I
Enrollment Status
Open to Enrollment