Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

NCT03865563 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: J1936IRB00164996
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

Conditions

Pancreatic Adenocarcinoma

Keywords

retrograde venous infusion; chemotherapy; gemcitabine; lipiodol

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Efficacy as assessed by Objective tumor response

  30 days

• Efficacy as assessed by change in serum CA19-9

  Change from baseline to 30 days

• Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples

  Change from baseline to 30 days

Study Arms (1)

Pancreatic adenocarcinoma

EXPERIMENTAL

Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol

Drug: Retrograde venous infusion of gemcitabine/lipiodol

Interventions

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.

Also known as: Pancreatic retrograde venous infusion (PRVI)

Pancreatic adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
• Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
• The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
• Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry
• Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]

You may not qualify if:

• The patient is able to give informed consent
• The patient, if a woman of childbearing potential, has a negative pregnancy test
• The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
• Life expectancy of at least 3 months
• Serum total bilirubin \> 3.0 mg/dL
• Creatinine \> 2.0 mg/dL
• Platelets \< 75,000/μL
• Hgb \< 8.0 g/dl
• ANC ≤ 1,000/μL
• INR \> 2.0
• Complete portal vein thrombosis or significant cavernous transformation of the portal vein
• Ascites (trace ascites on imaging is OK)
• The patient is pregnant or breast-feeding
• The patient is allergic to contrast media that cannot be readily managed or prevented with premedication
• Patients with peripheral neuropathy \[\> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)\]

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Ethiodized Oil

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Robert P Liddell, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: July 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)