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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

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date March 7, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Official Title  ICMJE Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Brief Summary Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Pancreatic Adenocarcinoma
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Pancreatic adenocarcinoma
Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
Intervention: Drug: Retrograde venous infusion of gemcitabine/lipiodol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert P Liddell, MD 4106142227 ext 4106142227 rliddel1@jhmi.edu
Contact: Beatriz P Kohler, RN, MPH, MBA 4106144212 ext 4106142227 bkohler@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03865563
Other Study ID Numbers  ICMJE IRB00164996
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert P Liddell, MD Johns Hopkins School of Medicine
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP