Adenovirus (RGDCRAdCOX2F)
ConditionAdenocarcinoma of Pancreas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Replicative Adenovirus Vector (RGDCRAdCOX2F)
Biological/VaccineRGDCRAdcox2F (RGD) is a "local" product and is provided through this study.
Treatment groups
18 Participants
are divided into 4 treatment groupsGroup A: Level: -1 RGDCRAdcox2F (RGD)Experimental treatment 1 intervention
Group B: Level: 1 RGDCRAdcox2F (RGD)Experimental treatment 1 intervention
Group C: Level: 2 RGDCRAdcox2F (RGD)Experimental treatment 1 intervention
Group D: Level: 3 RGDCRAdcox2F (RGD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov