Dettagli per singolo studio

DEC-NET Serial number GB456

Published online	30/08/2005 12.47.00
Last updated	30/08/2005 13.21.51


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	07/2004 70
Major Disease (ICD9 class)	MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE
Experimental drug
Cisplatin Treatment regimen (dosage and duration) 80mg/m2 on day 1 Given Centrally once every 4 weeks over 24 hours
Temozolomide Treatment regimen (dosage and duration) 200mg/m2 Taken orally on an empty stomach, for 5 days in a row every 4 weeks starting the day after cisplatin
Gender	Both
Age (range)	4 -21 years
Eligibility criteria
Inclusion criteria
Has a grade 3 or 4 glioma newly diagnosed or that has reoccurred Is well enough for chemotherapy Has satisfactory blood test results Is prepared to use reliable contraception if there is any chance they or their partner could become pregnant
Exclusion criteria
Presence of a brain stem tumour Has had complete resection of a glioma Having any other treatment for cancer Has had chemotherapy or radiotherapy in the last four months Has had cisplatin or temozolomide in the past Has intracranial hypertension
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design
Purpose of study
To determine the objective response rate with two courses of the combination of cisplatin-temozolomide in malignant glial tumours of children with the doses recommended by a completed phase I study
Primary outcomes
Objective response after two cycles of chemotherapy
Secondary outcomes
To assess the toxicity of the therapeutic combination To evaluate the relapse free survival at 1 and 2 years in patients treated at diagnosis which will be compared to that of the preceeding therapeutic study BCV (BCNU cisplatin VP16) To correlate the clinical and radiological response with expression of proteins MGMT/MMR by immunohistochemistry To evaluate the duration of clinical response in patients treated at the time of relapse. To study health status and the quality of life of treated patients To evaluate the ability of MR spectroscopy to predict response to chemotherapy in high grade astrocylomas
Summary of study design, objectives, and ongoing research findings
A patient with a diagnosis of incompletely resected high grade astrocytoma, if eligible, will be approached by the lead investigator in each centre. They will have a verbal explanation of the study, and receive appropriate patient information sheets. If consent is given, the patient will have a central venous line inserted under general anaesthetic prior to beginning therapy. Investigations prior to chemotherapy will include an echocardiogram (for some), GFR test (see below), blood testes (through the central line), audiogram, ECG (see below). The patient will be admitted to hospital for a period of at least 24 hours for treatment. Intravenous fluid will be given to ensure a high urine output. Anti-emetic drugs will be given prior to and during treatment as required. Close nursing obsevation is required throughout the patient's time in hospital. After 24 hours the patient may be discharged of well, and he/she will need to continue oral chemotherapy and anti-emetic thrapy for 5 days. It is likely that the patient will be readmitted at some time after chemotherapy because of a side effect, such as fever with neutropaenia. Local units have different policies for the management of complications, but such admissions typically last for 48-72 hours or more if unwell. The patient will need to attend out patients weekly, and will be re-evaluated clinicaly after 34 weeks (1 cycle). Provided there is no evidence of clinical deterioration, a second cycle of chemotherapy will be administered. After the second cycle, an MRI will be performed. This may be with additional scanner time to allow functiional MR imaging, if this is available locally and if the patient has given consent. The majority of patients are expected to go on to receive conventional rediotherapy at this stage. Patients who have a tumour response are eligible to receive a second period (2 cycles) of chemotherapy. All patients will have radiotherapy after a maximum of 4 cycles. After radiotherapy patients may continue with CISTEM up to a total of 7 courses, with investigations prior to each course as outlined above. After this, patients may continue Temozolomide alone according to patient and clinician preference.