Article
Therapy of medulloblastoma in adults (NOA 07) – a multicentric, population-based pilot study
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Published: | March 20, 2006 |
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Introduction: Medulloblastoma is rare in adults accounting for only 1-2% of all primary tumours of the central nervous system. Because of the small number of patients, there have been no randomized prospective studies so far. Treatment of adults,mostly compassionate, is based on retrospective analyses or paediatric protocols assuming that the biological features of the tumours in the adult population are similar to those of the paediatric one. The only pediatric study providing prospective data for young adults is HIT-91. This study showed a 5-year progression-free survival (5 PFS) of 78% for children with non-metastatic disease after surgery, radiotherapy and maintenance chemotherapy.
Methods: In the protocol [1], 30 adult patients older than 21 years with newly diagnosed medulloblastoma (or after surgical intervention and radiotherapy if the accomplishment was similar to the study protocol) will be treated according to the Philadelphia Protocol (which was also adopted in the paediatric protocol HIT-91). After surgical resection, radiotherapy with concomitant chemotherapy (Vincristine, 1,5 mg/m2, max 2mg, weekly) will be started within 2-4 weeks. Radiotherapy comprises radiation of the craniospinal axis (35,2 Gy, 1,6 Gy per fraction, 22 fractions) followed by a boost to the primary tumour (19,8 Gy, 1,8 Gy per fraction, 11 fractions) and, in case of metastatic disease, to the metastases (cerebral 1,8 Gy per fraction, 11 fractions; spinal 1,8 Gy per fraction, 8 fractions). Six weeks after finishing radiotherapy, “maintenance” chemotherapy including eight 6-week cycles consisting of Lomustine (CCNU, 75 mg/m2, day1), Cisplatin (70 mg/m2, day1) and Vincristine (1,5 mg/m2, max 2 mg, day 1, 8, 15) will be performed. Interruptions of the therapy due to toxicity (hematological toxicity, metabolic-laboratory) and thus feasibilitiy especially of the “maintenance” chemotherapy are defined as primary endpoints. Patients will be taken off the study in the case of progressive disease or severe side effects.
Discussion: This prospective study will evaluate the therapy of medulloblastoma in adults according to the Philadelphia Protocol. Based on our data, a protocol comparing the regimen of NOA-07 with a more experimental therapy will be performed (phase II).
[1] The proposed study is under revision in the “Studienhaus” of the Deutsche Krebsgesellschaft.