Actively Recruiting
Adenovirus (RGDCRAdCOX2F)
Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-01-07
18
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single center, Phase I dose finding study of a single direct tumor injection of an RGD modified conditionally replicative adenovirus (RGDCRAdcox2F) in persons with adenocarcinoma of the pancreas. The study is designed to determine the MTD of RGDCRAdCOX2F that corresponds to the maximum desired toxicity of ≤ 20%.
CONDITIONS
Official Title
Adenovirus (RGDCRAdCOX2F)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically documented pancreatic adenocarcinoma confined to the pancreas and regional lymph nodes after staging by CT or MRI and endoscopic ultrasound.
- One prior line of therapy allowed; at least 4 weeks must have passed since last treatment.
- Ability to tolerate esophagogastroduodenoscopy (EGD) and tumor accessible by endoscopic ultrasound.
- Age 18 years or older at time of consent.
- Normal cardiac and pulmonary function based on medical history and physical exam.
- Willingness to use at least two forms of effective birth control (one barrier method) for at least 1 month after Day 1 if participant has a partner of childbearing potential.
You will not qualify if you...
- Pregnant or breastfeeding; persons of child-bearing potential must have a negative pregnancy test within 14 days of enrollment.
- Other pancreatic malignancies such as neuroendocrine tumors and mucinous cystic tumors, or adenocarcinomas of ampulla, bile ducts, and duodenum.
- Tumors in mucosal regions or near airway, major blood vessel, or spinal cord that could cause occlusion or compression if swelling or necrosis occurs.
- Known HIV infection.
- Known or active acute or chronic hepatitis B or C infection.
- Serious concurrent infection or medical illness that could risk participant safety.
- Requires immunosuppression with prednisone ≥10 mg/day for more than 1 week.
- History or active autoimmune disease or conditions requiring systemic or immunosuppressive agents.
- Disease spread beyond regional lymph nodes.
- Active diffuse pancreatitis or inflammatory conditions.
- Prior gastrojejunostomy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
E
Edward Greeno, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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