Intratumoral Influenza Vaccine for Early Colorectal Cancer

NCT04591379 | Completed Phase 2 DMC

• 1 other identifier: REG-083-2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy - local immunological changes

  Pathological specimens from day of treatment (day 0) and surgery (day 7-14 after treatment)

Other Outcomes (2)

• Efficacy - systemic immunological changes

  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)

• Quality of recovery

  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)

Study Arms (1)

Intervention arm

EXPERIMENTAL

Drug: Influenza Vaccines

Interventions

Influenza Vaccines DRUG

Intratumoral application of an unattenuated influenza vaccine

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37172969 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ismail Gögenur, Professor

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: October 19, 2020
• Study Start: February 26, 2021
• Primary Completion: September 22, 2021
• Study Completion: November 1, 2021
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and informed consent form will be available upon start of recruitment of patients

Locations

DK (1)