Intratumoral Influenza Vaccine for Early Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intratumoral Influenza Vaccine for Early Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Influenza Vaccines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Drug: Influenza Vaccines<br>* Intratumoral application of an unattenuated influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day of surgery (day 7-14 after treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Pathological specimens from day of treatment (day 0) and surgery (day 7-14 after treatment) |