Intratumoral Influenza Vaccine for Early Colorectal Cancer

NCT ID: NCT04591379

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2021-11-01

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

Group Type: EXPERIMENTAL

Influenza Vaccines

Intervention Type: DRUG

Intratumoral application of an unattenuated influenza vaccine

Interventions

Influenza Vaccines

Intratumoral application of an unattenuated influenza vaccine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismail Gögenur, Professor

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Zealand University Hospital

Køge, Region Sjælland, Denmark

Countries

Denmark

References

Gogenur M, Balsevicius L, Bulut M, Colak N, Justesen TF, Fiehn AK, Jensen MB, Host-Rasmussen K, Cappelen B, Gaggar S, Tajik A, Zahid JA, Bennedsen ALB, D'Ondes TDB, Raskov H, Saekmose SG, Hansen LB, Salanti A, Brix S, Gogenur I. Neoadjuvant intratumoral influenza vaccine treatment in patients with proficient mismatch repair colorectal cancer leads to increased tumor infiltration of CD8+ T cells and upregulation of PD-L1: a phase 1/2 clinical trial. J Immunother Cancer. 2023 May;11(5):e006774. doi: 10.1136/jitc-2023-006774.

Reference Type: DERIVED

PMID: 37172969 (View on PubMed)

Other Identifiers

REG-083-2020

Identifier Type: -

Identifier Source: org_study_id