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Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

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ClinicalTrials.gov Identifier: NCT03865563
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Retrograde venous infusion of gemcitabine/lipiodol Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Pancreatic adenocarcinoma
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
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.
Other Name: Pancreatic retrograde venous infusion (PRVI)




Primary Outcome Measures :
  1. Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® [ Time Frame: 30 days ]
    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.

  2. Safety as measured by number of participants with Grade 3, 4, and 5 toxicities [ Time Frame: 30 days ]
    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


Secondary Outcome Measures :
  1. Efficacy as assessed by Objective tumor response [ Time Frame: 30 days ]
    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.

  2. Efficacy as assessed by change in serum CA19-9 [ Time Frame: Change from baseline to 30 days ]
    Change in serum CA19-9 measurements pre- and post-PRVI.

  3. Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples [ Time Frame: Change from baseline to 30 days ]
    Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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]
  • Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)
  • 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

Exclusion Criteria:

  • 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)]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865563


Contacts
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Contact: Robert P Liddell, MD 4106142227 ext 4106142227 rliddel1@jhmi.edu
Contact: Beatriz P Kohler, RN, MPH, MBA 4106144212 ext 4106142227 bkohler@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Robert P Liddell, MD    410-614-2227 ext 4106142227    rliddel1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Robert P Liddell, MD Johns Hopkins School of Medicine

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03865563     History of Changes
Other Study ID Numbers: IRB00164996
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
retrograde venous infusion
chemotherapy
gemcitabine
lipiodol

Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Ethiodized Oil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs