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A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer

NCT01539824 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-25

Study results available
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Summary

The purpose of this study is to investigate the safety and effects of IMM 101 in combination with a single targeted dose of radiation in patients with metastatic colorectal cancer in whom chemotherapy or other treatment has not been effective. Administration of radiation (using the CyberKnife) to the target tumour growth in the liver results in the release of tumour material. IMM-101 may help the immune system to react to the tumour material released from the damaged tumour, and so have a beneficial effect in slowing down the rate of growth of other tumour growths in the liver and other organs.

Conditions

Interventions

BIOLOGICAL

Mycobacterium obuense

IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.

RADIATION

SBRT

The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.

Sponsors & Collaborators

  • Immodulon Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Andrew Gaya · Leaders In Oncology Care, Harley St, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-30
Primary Completion
2014-03-27
Completion
2014-03-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539824 on ClinicalTrials.gov