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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%.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
18 participants in 4 patient groups
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Central trial contact
Edward Greeno, MD
Data sourced from clinicaltrials.gov
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