| DEC-NET Serial number IT428 |
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| Published online | 24/06/2005 16.35.00 |
| Last updated | 30/06/2005 16.13.48 |
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| Other protocol ID number | |
| Current trial status | Planned (i.e. not yet recruiting participants) |
Major Disease
(ICD9 class) | MALIGNANT NEOPLASM OF OTHER ENDOCRINE GLANDS AND R |
| Experimental drug |
ch14.18/ CHO antibody
Treatment regimen (dosage and duration)
N/A |
| Gender | Both |
| Age (range) | 1-21 years |
Eligibility criteria |
| Inclusion criteria |
| Advanced neuroblastoma |
| Exclusion criteria |
| - previous treatment with monoclonal anti-NB antibody
- inadequate general conditions
- patient on immunosuppresant therapy
- previous allogenic transplant
- parents. decision |
Trial design/methodology |
| Phase | 1 |
| Kind of study | Efficacy
Safety
Pharmacokinetics |
| Design | Randomised
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| Purpose of study |
| The primary objective of this trial is the re-evaluation of toxicity of the new ch14.18/CHO antibody. The secondary objectives include the determination of pharmacokinetics and immunostimulation in patients receiving ch14.18/CHO therapy, particularly the determination of activation of immune effector cells and complement during and after application of ch14.18/CHO. Subsequently, we will evaluate the clinical effect of this treatment on the course of the disease. |
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| Summary of study design, objectives, and ongoing research findings |
| The European Neuroblastoma Group designed a phase III study to test the clinical efficacy of immunotherapy with CH 14.18. Three different dosages will be studied for 5 days and patients enrolled who conclude treatment with at least one cycle will pass on to the next. Patients who do not show toxicity and whose disease state does not worsen will undergo two further treatment cycles without dose increase. This will therefore be the preliminary study to the phase III study. Patients 1 to 21 years old with advanced neuroblastoma can be enrolled. Before being treated, patiens will undergo routine exams for neuroblastoma, including bone marrow aspiration. These will be repeated after 28 days of enrolment. Patients will also have their blood drawn for tests through the central venous catheter. |
