A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01539824|
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : December 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Biological: Mycobacterium obuense Radiation: SBRT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||February 2012|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
Experimental: IMM-101 plus SBRT
The treatment regimen with IMM-101 (Mycobacterium obuense) will be every 2 weeks for the first three doses with the last of these doses being on the same day as the radiotherapy by CyberKnife treatment on a liver lesion targeted by the Principal Investigator. Following a rest of 4 weeks, patients will again receive IMM-101 every 2 weeks for the next 3 doses followed by a further 4 weeks rest. Thereafter, IMM-101 will be given at 4 week intervals for up to 12 months or until patient withdrawal for any reason
Biological: Mycobacterium obuense
IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
Other Name: IMM-101Radiation: 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.
- Disease stabilisation rate [ Time Frame: 24 weeks ]The disease stabilisation rate at 24 weeks defined as the proportion of patients with a complete response, partial response or stable disease in accordance with immune-related response criteria.
- safety and tolerability profiles [ Time Frame: 48 weeks ]
No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by:
- Local and systemic toxicities.
- Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Safety and tolerability will be monitored through the study by a Data Monitoring Committee (DMC)
- Objective response rate [ Time Frame: 12, 24, 36 and 48 weeks ]
- Disease stabilisation rate [ Time Frame: 12, 36 and 48 weeks ]
- Overall disease stabilisation rate [ Time Frame: End of study ]
- Overall response rate [ Time Frame: End of study ]
- Progression-free survival [ Time Frame: 12, 24, 36 and 48 weeks ]
- Survival [ Time Frame: 12, 24, 36 and 48 weeks ]
- Tumour Markers [ Time Frame: 12, 24, 36 and 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539824
|HCA International, The Sarah Cannon Research Institute|
|London, United Kingdom, W1G 6AD|
|The London Clinic|
|London, United Kingdom|
|Principal Investigator:||Andrew Gaya||Leaders In Oncology Care, Harley St, London|