IMM-101 treatment, combined with CyberKnife, in Colorectal Cancer

• Research type

  Research Study

• Full title

  A Phase II, Single Arm, Investigative Study of IMM-101 in Combination with Radiation Induced Tumour Necrosis in Patients with Previously Treated Colorectal Cancer

• IRAS ID

  94005

• Contact name

  Andrew Gaya

• Sponsor organisation

  Immodulon Therapeutics Ltd

• Eudract number

  2011-003958-85

• ISRCTN Number

  not issued

• Research summary

  Colorectal cancer is the second leading cause of cancer-related death in Western nations and the third most common cancer worldwide with approximately one million new cases diagnosed yearly. Despite advances in screening procedures, 25% of patients still present with disease that has spread to other organs i.e. metastatic disease. There is no curative treatment available for patients not suitable for surgical clearance of the cancer. Most of these patients, for whom there is no curative treatment, die of their disease. Therefore, there is a need for new active treatment options in this setting. There is published research suggesting that certain forms of immunotherapy may be more effective when there is localised damage to a metastasis. There is also research to suggest causing damage to one metastasis, on a single occasion, may produce a beneficial response in other metastases, not treated with radiation. Patients eligible for this study will have colorectal cancer with measurable metastases and evidence of disease progression following chemotherapy. The patients will have been advised there are no further chemotherapy options available or may have refused further chemotherapy. This study will investigate the effect of combination of damaging a single tumour growth (metastasis) with radio-surgery and boosting the immune system using an investigational drug, on reducing tumour growth. Radio-surgery will be delivered by the CyberKnife system, which delivers a large, targeted dose of radiation, with extreme accuracy, to a single metastasis. The investigational drug is IMM-101, which contains a specific organism (Mycobacterium obuense) that has been killed at high temperature so that it is not infectious but still can produce immunological effects.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/2030

• Date of REC Opinion

  3 Feb 2012

• REC opinion

  Further Information Favourable Opinion