Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Thiotepa

Criteria

Inclusion Criteria:

1. Type of tumor:

• Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells).

• Incompletely resected local medulloblastoma with a residue > 1.5 cm2.

• Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection).

• Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection).

• Local and/or metastatic sustentorial PNET.

2. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.

3. Age at diagnosis of S-PNET of more than 10 years and less than 20 years.

4. Nutritional and general status compatible with treatment, Lansky score > 60.

5. Estimated life expectancy > 1 months.

6. Radiographs must be available for the second reading in dicom format on a CD-ROM.

7. Hematological function at diagnosis: PMN > 1.0 x 109/l and platelets > 100 x 109/l.

8. Hepatic function at diagnosis: serum bilirubin < 1.5 times normal value; ASAT and ALAT < 2.5 times normal values; prothrombin time > 50%; fibrinogen > 1.5 g/l.

9. Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years < 65 micromol/l; 15 to 18 years < 110 micromol/l.

10. No organ toxicity (Grade > 2 according to NCI-CTC coding, version 2.0)

11. No other concomitant anti-cancer treatment.

12. No prior anti-cancer therapy.

13. No prior irradiation.

14. Written informed consent signed by both parents or legal guardians

Exclusion Criteria:

1. Failure to comply with one of the inclusion criteria.

2. Severe or life-threatening infection.

3. Uncontrolled active or symptomatic intracranial hypertension.

4. Refusal of parents or legal guardian.

5. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons