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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intratumoral application of an unattenuated influenza vaccine
Zealand University Hospital
Køge, Region Sjælland, Denmark
Safety - Adverse reactions are classified according to CTCAE version 4.0
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.
Time frame: Day of surgery (day 7-14 after treatment)
Efficacy - local immunological changes
To investigate if intratumoral influenza vaccine will induce immunologic invasion of the primary tumor This will be analyzed by immunhistochemistry and NanoString
Time frame: Pathological specimens from day of treatment (day 0) and surgery (day 7-14 after treatment)
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