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Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

Primary Purpose

Pancreatic Adenocarcinoma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Retrograde venous infusion of gemcitabine/lipiodol
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring retrograde venous infusion, chemotherapy, gemcitabine, lipiodol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)]

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic adenocarcinoma

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
Efficacy as assessed by change in serum CA19-9
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
Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.

Full Information

First Posted
March 5, 2019
Last Updated
January 22, 2020
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT03865563
Brief Title
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Official Title
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
We need to make significant adjustments to proposed drug and its delivery method
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
retrograde venous infusion, chemotherapy, gemcitabine, lipiodol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pancreatic adenocarcinoma
Arm Type
Experimental
Arm Description
Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
Intervention Type
Drug
Intervention Name(s)
Retrograde venous infusion of gemcitabine/lipiodol
Other Intervention Name(s)
Pancreatic retrograde venous infusion (PRVI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
Description
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.
Time Frame
30 days
Title
Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Efficacy as assessed by Objective tumor response
Description
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.
Time Frame
30 days
Title
Efficacy as assessed by change in serum CA19-9
Description
Change in serum CA19-9 measurements pre- and post-PRVI.
Time Frame
Change from baseline to 30 days
Title
Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples
Description
Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.
Time Frame
Change from baseline to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Liddell, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Selective Transvenous Chemoembolization of Primary Pancreatic Tumors

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