Direct tumor injection of a modified adenovirus for pancreatic cancer
A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma
This study is testing a new treatment that uses a modified virus injected directly into pancreatic tumors to see if it is safe for people with localized pancreatic cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06693986 on ClinicalTrials.gov |
What this trial studies
This Phase I interventional study evaluates the safety and maximum tolerated dose of RGDCRAdCOX2F, a modified adenovirus, administered directly into tumors of patients with adenocarcinoma of the pancreas. The trial aims to determine the maximum desired toxicity level while assessing the feasibility of the treatment approach. Participants must have histologically confirmed pancreatic adenocarcinoma that is localized and accessible for injection. The study is conducted at a single center, the Masonic Cancer Center at the University of Minnesota.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized pancreatic adenocarcinoma who have had one prior line of therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have significant cardiac or pulmonary issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with pancreatic adenocarcinoma.
How similar studies have performed: While this approach is innovative, similar studies using modified adenoviruses for cancer treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes after staging by CT or MRI and endoscopic ultrasound. * One prior line of therapy is permitted (i.e. neo-adjuvant therapy); however, at least 4 weeks must have elapsed between the last dose of drug and the injection of RGDCRAdCOX2F. * Must be able to tolerate esophagogastroduodenoscopy (EGD) and the tumor must be accessible by endoscopic ultra sound. Participants will be excluded if obtaining biopsies are deemed unsafe or not feasible. * Age 18 years of age or older at the time of consent * Normal cardiac and pulmonary function based on history and physical exam * Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) for at least 1 month after Day 1. Exclusion Criteria: * Pregnant or breastfeeding. Persons of child-bearing potential must have a negative pregnancy test (serum or urine) with 14 days of study enrollment. * Other pancreatic malignancies (e.g., neuroendocrine tumors and mucinous cystic) and adenocarcinomas of the ampulla, bile ducts, and duodenum. * Tumors in mucosal regions or close to an airway, major blood vessel, or spinal cord that in the opinion of the enrolling investigator could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. * Known history of human immunodeficiency virus (HIV) infection * Known history of or active acute or chronic active hepatitis B or C infection * Serious concurrent infection or medical illness, which in the enrolling investigator's opinion would jeopardize the ability of the participant to receive the treatment outlined in this protocol with reasonable safety. * Requires immunosuppression ≥10mg/day of prednisone for more than 1 week. * History of or active known or suspected autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents. * Disease beyond the regional lymph nodes * Active diffuse pancreatitis * Active inflammatory conditions * Prior gastrojejunostomy
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Edward Greeno, MD
- Email: green048@umn.edu
- Phone: 612-626-6418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.