E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant diseases of the blood requiring chemotherapy and/or radiation therapy of head and neck
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066481 |
E.1.2 | Term | Hematological malignancy |
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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 |
To evaluate whether the administration of bismuth as described in the protocol will prove to have a protective effect on healthy cells. Whether bismuth will counteract the acute (and possibly subacute) side effects that are seen in these patients due to toxicity from chemotherapy and radiation therapy (e.g. stomatitis and enteritis) will be evaluated also. |
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E.2.2 | Secondary objectives of the trial |
To identify the biological effect(s) of administered bismuth. This will also include the identification of the effect of bismuth on MT regulation and expression in tumour as well as healthy (control) tissue. Other survival/growth factors will be also be shown. Finally, the intracellular incidence of bismuth compared with administered bismuth will be monitored. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of 18 years or over who have been referred to Department of Haematology (L), Herlev Hospital for treatment of haematological malignancies by means of the following regimes: high dose methotrexat, high dose vepesid, high dose melphalan, BEAM, induction treatment by ALL, as well as patients treated with radiation therapy of the oral cavity. Only patients who have signed an informed consent form will be included. |
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E.4 | Principal exclusion criteria |
1. Pregnant women and nursing mothers (women of child bearing age must apply secure contraceptive measures) 2. No acceptance from patient 3. Known hypersensitivity to bismuth or other tablet content 4. Severe renal insufficiency with creatinin clearance below 25 ml/min. 5. Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth) 6. Other experimental treatment within the previous 4 weeks. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate if the administration of bismuth in relation to intensive chemotherapy and radiation therapy will reduce the toxicity of the mucous membrane |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | No |
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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One month after the 50th patient is included in the study |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |