| DEC-NET Serial number FR596 |
| |
| Published online | 12/10/2006 11.19.00 |
| Last updated | 11/09/2006 16.47.03 |
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| Other protocol ID number | CSET-2002/978 |
| Current trial status | Closed to recruitment of participants: follow-up continuing |
Major Disease
(ICD9 class) | MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN |
| Experimental drug |
CISPLATIN
Treatment regimen (dosage and duration)
Cisplatin IV over 3 hours on day 1.
Treatment repeats every 28 days for up to 7 courses. |
TEMOZOLOMIDE
Treatment regimen (dosage and duration)
Oral temozolomide once daily on days 2-6. Treatment repeats every 28 days for up to 7 courses |
| Gender | Both |
| Age (range) | 4 - 21 years old |
Eligibility criteria |
| Inclusion criteria |
| -Age from 4th birthday and younger than 21st birthday
-Histologically documented malignant glial tumour (WHO classification grade III and IV) : anaplastic astrocytoma,anaplastic oligodendroglioma, anaplasticoligoastrocytoma and anaplastic mixed tumour,
-Measurable and evaluable disease by the imaging criteria (MRI),
-Patient not previously treated by either of the two drugs,
-No other concurrent anticancer treatment,
-Good general and nutritional state according to NCI-CTC grade < 2, Lansky Score > 30,
-Organ toxicity ≤ grade 2
-Neutrophil count ≥ 1,000/mm³ and Platelet count ≥ 100,000/mm³
-Bilirubin ≤ 1.5 times upper limit of normal (ULN)
-AST and ALT ≤ 2.5 times ULN
-Prothrombin ≥ 50%
-Fibrinogen ≥ 1.5 g/L
-Creatinine normal for age
Creatinine ≤ 65 µmol/L (4-15 years of age)
Creatinine ≤ 110 µmol/L (15-20 years of age)
-Audiogram with toxicity grade ≤ 2
-Written informed consent,
-For the patients in age to procreate, a barrier method of contraception is recommended, |
| Exclusion criteria |
| -Malignant brain stem tumours
-Severe or life-threatening infection
-Uncontrolled developing or symptomatic intracranial hypertension |
Trial design/methodology |
| Phase | 2 |
| Kind of study | Efficacy
|
| Design | |
| Purpose of study |
| The primary objective:
-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 |
| -Radiological response after two courses of Temozolomide-Cisplatin
|
| Secondary outcomes |
| -Progression-free survival;
-Health status and quality of life;
-Toxicity |
| Summary of study design, objectives, and ongoing research findings |
| This is a multicenter, open-label, nonrandomized, 3 parallel-cohort study. Patients are stratified according to disease status (newly diagnosed vs relapsed (B)). Patients with newly diagnosed disease are further stratified according to spread of disease [localized (A1)and measurable vs diffuse unmeasurable(A2)].
1/Newly diagnosed patients (A)receive CISTEM chemotherapy comprising cisplatin IV over 3 hours on day 1 and oral temozolomide once daily on days 2-6. Treatment repeats every 28 days for up to 7 courses. Patients who achieve responsive or stable disease after 2 courses receive 2 more courses of CISTEM chemotherapy and then undergo radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients may receive up to 3 more courses of CISTEM chemotherapy for a total of 7 courses.
2/Relapsed Patients (B)receive CISTEM chemotherapy for up to 7 courses as in stratum I. Patients who reach the maximum dose allowed for cisplatin may receive oral temozolomide alone indefinitely. |
