A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer
Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01539824 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mycobacterium obuense (Biological); SBRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Immodulon Therapeutics Ltd
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Stabilisation Rate |
0; 0; 0 | — |
| SECONDARY Safety and Tolerability Profiles |
0; 156 | — |
| SECONDARY Objective Response Rate |
0; 0; 0; 0 | — |
| SECONDARY Disease Stabilisation Rate |
0; 0; 0 | — |
| SECONDARY Overall Disease Stabilisation Rate |
0; 0; 0 | — |
| SECONDARY Overall Response Rate |
0; 0; 0; 0 | — |
| SECONDARY Survival |
10; 6; 3; 2 | — |
Summary
Eligibility Criteria
Inclusion criteria
Male or female; aged ≥ 18 years. Histologically confirmed colorectal adenocarcinoma. Documented evidence of disease progression following at least one line of chemotherapy.
No further standard chemotherapy options available have refused further chemotherapy.
Metastatic lesions in at least two sites in the liver (+/- other sites) suitable for bidimensional and volumetric evaluation by CT scan.
World Health Organization (WHO) performance status of 0-2. Cockcroft calculated Glomerular Filtration Rate of > 40mL/min at screening. Life expectancy, in the opinion of the Investigator, of > 3 months from screening.
Exclusion Criteria
Evidence of central nervous system metastasis. Severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments.
Any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years earlier and there are no signs of recurrence.
Serum albumin 70 mg/L at screening. Transaminases (ALT or AST) > 5 X Upper Limit of Normal at screening. Bilirubin level > 2 X Upper Limit of Normal at screening. Radiotherapy in the 12 weeks before screening. Depot corticosteroid use in the 6 weeks before screening. Chronic use of any systemic corticosteroids (> 10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period before the first administration of study drug.
Woman of child-bearing potential who is not using an approved method of birth control Any investigational product administration in the 3 months before screening. Contraindication to CT scan, e.g., allergy to iodine based contrast medium. A surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
Any uncontrolled concomitant disease which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study.
History of serious adverse reaction or serious hypersensitivity to any drug that in the opinion of the Investigator may raise a safety concern.
Any previous treatment with IMM-101 or related mycobacterial immunotherapy (prior bacillus Calmette-Guerin (BCG) vaccination against Tuberculosis is allowed).
Known history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C.
Unable or unwilling to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT01539824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.