RECRUITING

Adenovirus (RGDCRAdCOX2F)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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%.

Official Title

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma

Quick Facts

Study Start:2024-12-27

Study Completion:2029-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06693986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 * 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

Inclusion Criteria

Exclusion 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.

* 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
* 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

Contacts and Locations

Study Contact

Edward Greeno, MD

CONTACT

612-626-6418

green048@umn.edu

Study Locations (Sites)

Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-27

Study Completion Date2029-10-15

Study Record Updates

Study Start Date2024-12-27

Study Completion Date2029-10-15

Terms related to this study

Additional Relevant MeSH Terms

Adenocarcinoma of Pancreas