Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intratumoral Influenza Vaccine for Early Colorectal Cancer

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: NCT04591379
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : March 12, 2021
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this explorative phase II clinical trial is to establish the safety and efficacy of intratumoral influenza vaccine in patients with colorectal cancer, as an additive treatment prior to intended curative surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Influenza Vaccines Phase 2

Detailed Description:

This is an explorative phase 2 clinical trial which will be conducted in two phases. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with intratumoral influenza vaccine as a down staging and immune response enhancing treatment prior to intended curative surgery.

The first part of the study will be conducted as a pilot study. Six patients with histologically verified or clinically suspicious sigmoid colon cancer who are planned to undergo curative surgery will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

If the pilot study finishes without violating any stop rules and without any serious adverse events the second part of the study will be initiated. This will be conducted as a phase 2 study where 24 patients with histologically verified or clinically suspicious sigmoid colon cancer and rectal cancer will be included. Patients will be recruited from the Department of Surgery, Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Standard treatment involves intended curative surgery within two weeks after the diagnosis. The treatment will be performed within a few days and it will be ensured that the experimental treatment will not lead to a significant delay of intended curative surgery.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intratumoral Influenza Vaccine for Early Colorectal Cancer
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention arm Drug: Influenza Vaccines
Intratumoral application of an unattenuated influenza vaccine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety - Adverse reactions are classified according to CTCAE version 4.0 [ Time Frame: Day of surgery (day 7-14 after treatment) ]

    To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.

    Adverse events / reactions are recorded from day of treatment (Day 0) until the surgery, as it will be difficult to differ between adverse events/reactions to the experimental treatment or surgery. All adverse events / reactions should be described in medical terminology in the patient's file and recorded in case report forms (CRF). The following information must be recorded: start date/date when observed, severity, any initiated treatment, assessment of the AE if it meets the criteria for SAE, end date, and relationship to study drug. For AEs that meet the criteria for SAE, the outcome must be recorded.



Secondary Outcome Measures :
  1. Efficacy - local immunological changes [ Time Frame: Pathological specimens from day of treatment (day 0) and surgery (day 7-14 after treatment) ]
    To investigate if intratumoral influenza vaccine will induce immunologic invasion of the primary tumor This will be analyzed by immunhistochemistry and NanoString


Other Outcome Measures:
  1. Efficacy - systemic immunological changes [ Time Frame: Blood samples from the day of treatment (day 0), before surgery (day 7-14 after treatment), after surgery (postOP day 1-2) and postoperative follow-up (postOP day 12-16) ]
    To investigate if the treatment will induce a systemic immunologic response.

  2. Quality of recovery [ Time Frame: Assessed before treatment (day 0), before surgery (day 7-14 after treatment), after surgery (postOP day 1) and postoperative follow-up (postOP day 12-16) ]
    To assess quality of recovery for patients recruited into this trial. A quality of recovery questionnaire (QoR-15) will be given to patients pre- and post-treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

  • Patients must be mentally capable of understanding the information given.
  • Patients must give written informed consent.
  • Clinically suspected or histologically verified malignant tumor of the rectum or sigmoid colon.
  • Tumor described as passable at index endoscopy.
  • Men or women aged at least 18 years.
  • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.

Exclusion Criteria:

  • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
  • Ongoing immunosuppressive treatment.
  • Concurrent treatment with an investigational medicinal product.
  • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
  • Advanced tumor stages, clinical UICC stage IV.
  • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
  • Acute surgical resection.
  • Pregnancy
  • Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9
  • Acute febrile illness
  • Acute infectious disease
  • Influenza vaccine administered within 30 days before study inclusion
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04591379


Contacts
Layout table for location contacts
Contact: Mikail Gögenur, MD 31429929 ext 0045 mgog@regionsjaelland.dk
Contact: Ismail Gögenur, Professor 26356426 ext 0045 igo@regionsjaelland.dk

Locations
Layout table for location information
Denmark
Zealand University Hospital Recruiting
Køge, Zealand, Denmark, 4600
Contact: Mikail Gögenur, MD    31429929 ext 0045    mgog@regionsjaelland.dk   
Contact: Ismail Gögenur, Professor    26356426 ext 0045    igo@regionsjaelland.dk   
Principal Investigator: Ismail Gögenur, Professor         
Sub-Investigator: Mikail Gögenur, MD         
Sub-Investigator: Noor Hadi, medical student         
Sub-Investigator: Nesibe Colak, medical student         
Sponsors and Collaborators
Zealand University Hospital
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Ismail Gögenur, Professor Zealand University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04591379    
Other Study ID Numbers: REG-083-2020
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Study protocol and informed consent form will be available upon start of recruitment of patients

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases