E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inoperable metastatic colorectal cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009951 |
E.1.2 | Term | Colon cancer NOS |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to investigate whether an immune cell population that acts against the clinical benefit of the patient (i.e. in favour of the development of cancer) can be specifically reduced. This would lead to enhanced anti-tumour immune responses observed, as it has already been observed in rodents.
The research question will be asked in patients with inoperable metastatic colorectal cancer. |
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E.2.2 | Secondary objectives of the trial |
Secondary research objectives are to try to establish a correlation between immune responses and clinical outcome, to compare the safety profile of the treatment groups and to characterise the reduction of the cell population that acts against the patient's benefit.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patient able to give informed consent personally -Signed and dated written informed consent -Age ≥ 18 years -Clinical diagnosis of inoperable colorectal cancer -WHO performance status 0-2 -Responding or stable disease as defined by oncologist following 12 weeks of front-line chemotherapy for metastatic disease, as demonstrated on CT scan in comparison with pre-treatment CT scan (RECIST), within 4 weeks of trial entry -Any cancer related symptoms are under control with standard non-chemotherapy medications -Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count ≥ 500/µL, Absolute Neutrophil Count >1200/µL, Platelet Count >100,000/µL
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E.4 | Principal exclusion criteria |
-Patient unable to give informed consent personally -Creatinine level >1.5 Upper Limit of Normal (ULN) -Bilirubin level >50 µmol/l -Alkaline Phosphatase >3 ULN -Aspartate Aminotransferase and Alanine Aminotransferase >2 ULN -Prothrombin time >18sec -Prior exposure to TroVax® -Life expectancy of less than 3 months -Patient has relapsed -Diagnosed as being immunosupressed, receiving oral steroids (nasal sprays and inhalers are permitted) or receiving immunosuppressive therapy for oncology disorders, or following transplant -Patient has completed chemotherapy less than 2 weeks from the start of the treatment -Subject has clinically apparent/active autoimmune disease (prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s disease, Hashimoto’s thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus and rheumatoid arthritis). Note: subjects with non-insulin dependent diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease -Subject has a platelet count prior to start of chemotherapy >400,000/μL; Haemoglobin <11g/dL; Monocytes >80,000/μL. -Significant cancer related symptoms requiring immediate treatment with chemotherapy -“Currently active” second malignancy, other than non-melanoma skin cancer. Subjects are not considered to have a "currently active” malignancy if they have completed therapy more than 5 years previously and have no known evidence of residual or recurrent disease -Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigating physician makes it undesirable for the patient to participate in the trial. No participant should have a serious or uncontrolled intercurrent infection (including those positive for HIV) -Psychiatric illnesses/social situations that limit compliance with protocol requirements -Allergy to egg proteins, cyclophosphamide, neomycin or allergic response to vaccinia vaccines -Known cerebral metastases (known from previous investigations or clinically detectable) -Haemorrhagic cystitis -Severe infection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Development or increase in anti-5T4 i)T-cell responses ii)B-cell responses (antibodies) in patients treated with cyclophosphamide and TroVax versus TroVax alone or cyclophsophamide alone or untreated patients at week 7 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Study of immune system responses |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is one year after the last visit of the last patient. We require 1 year of follow-up to collect disease progression, toxicity and survival information to satisfy the secondary objectives of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |