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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00164996 | Other Identifier | JHM IRB |
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We need to make significant adjustments to proposed drug and its delivery method
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Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.
Complete enrollment in 12 months from date of enrollment of first study subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic adenocarcinoma | Experimental | Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde venous infusion of gemcitabine/lipiodol | Drug | Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® | Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor. | 30 days |
| Safety as measured by number of participants with Grade 3, 4, and 5 toxicities | Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as assessed by Objective tumor response | Objective tumor response is measured as number of participants with response as determined by RECIST 1.1 criteria to assess change in tumor size and percent tumor enhancement as visualized on pancreatic protocol CT scans. | 30 days |
| Efficacy as assessed by change in serum CA19-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Liddell, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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This is an open-label, single institution, single-arm pilot study, designed to assess the feasibility, safety and efficacy of retrograde venous infusion of gemcitabine/Lipiodol® administered in a neoadjuvant setting for the treatment of patients with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma.
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Change in serum CA19-9 measurements pre- and post-PRVI. |
| Change from baseline to 30 days |
| Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples | Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI. | Change from baseline to 30 days |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |