Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts (CHARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03085004
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Matthew T. Moyer, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.

Condition or disease Intervention/treatment Phase
Pancreatic Cyst EUS-FNA Drug: Ethanol Drug: Normal saline Drug: Paclitaxel + Gemcitabine admixture Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a Prospective, Randomized, Double-blind, Multi-center Clinical Trial
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Active Comparator: Control Group
Cyst will be lavaged for 3 to 5 minutes with 98% ethanol. Following lavage with 98% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).
Drug: Ethanol
The cyst will be lavaged for 3 to 5 minutes using 98% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

Drug: Paclitaxel + Gemcitabine admixture
Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Experimental: Study group
Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).
Drug: Normal saline
The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

Drug: Paclitaxel + Gemcitabine admixture
Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.




Primary Outcome Measures :
  1. Percentage of subjects achieving complete cyst resolution at 12 months [ Time Frame: 12 months post initial treatment ]
    This is defined as Complete response greater than or equal to 95% reduction in cyst volume and measured by "r" as cyst volume 4/3×π×r3 at 12 months post initial treatment

  2. Incidence of serious and minor adverse events occurring within 30 days post ablation [ Time Frame: 30 days post EUS-FNI procedure ]
    Based on definition of serious and minor adverse events, the two arms will be compared with respect to adverse events that took place within 30 days after the subject's procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult subjects over the age of 18.
  • Patients with a previously detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts.
  • Ability to give written informed consent.
  • Capable of safely undergoing endoscopy with deep sedation or general anesthesia.

Exclusion Criteria:

  • Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma).
  • Known or suspected pancreatic cancer or pathologic lymphadenopathy.
  • Cysts with the following high risk features: main pancreatic duct dilation of > 5mm, epithelial type mural nodules, pathologically thick wall/septation (> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst, pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity.
  • Septated cysts with > 4 compartments.
  • Confirmed pancreatitis within the last 3 months.
  • Baseline lab values at the time of consent of: white blood cells (K/uL) > 14 or < 2, hematocrit < 30, platelets (K/uL) <30,000, non-pharmacologic INR > 1.7, CA19-9 >2X ULN(unit/ml), lipase (U/L) > 2 X the upper limit of normal, creatinine (mg/dl) > 3.0 unless stable on renal replacement therapy, ALT (U/L) > 500, total bilirubin (mg/dl) > 2.5.
  • Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst).
  • Pregnancy, breastfeeding, or incarcerated individual.

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): NCT03085004


Contacts
Layout table for location contacts
Contact: Matthew T. Moyer, MD, MS 717-531-3694 mmoyer@pennstatehealth.psu.edu
Contact: Courtney Lester 717-531-0003 ext 287992 clester1@pennstatehealth.psu.edu

Locations
Layout table for location information
United States, Indiana
Indiana University Health University Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: John M. DeWitt, MD    317-944-1113    jodewitt@iu.edu   
Contact: Martha Mendez, RN    317-278-2586    mwmendez@iu.edu   
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Stuart Gordon, MD    603-650-5261    stuart.r.gordon@hitchcock.org   
Contact: Jessica Chevalier, CCRP    603-653-9033    Jessica.I.Chevalier@hitchcock.org   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Matthew T. Moyer, MD, MS    717-531-3694    mmoyer@pennstatehealth.psu.edu   
Contact: Courtney Lester    717-531-0003 ext 287992    clester1@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Matthew T. Moyer, MD, MS Milton S. Hershey Medical Center

Layout table for additonal information
Responsible Party: Matthew T. Moyer, Associate Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03085004     History of Changes
Other Study ID Numbers: 5206
1R01CA222648 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew T. Moyer, Milton S. Hershey Medical Center:
Pancreatic cyst
EUS-FNA
Chemotherapy
Endoscopic ultrasound-guided fine needle infusion
paclitaxel
gemcitabine
cyst ablation

Additional relevant MeSH terms:
Layout table for MeSH terms
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Ethanol
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Central Nervous System Depressants