Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis (NCT00864318) | Clinical Trial Compass
CompletedPhase 2
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
France101 participantsStarted 2009-03-13
Plain-language summary
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.
Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.
This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal
✓. Age \>= 18 years old
✓. Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose germ cell tumor without histology (TGNS)
✓. Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 :
✓. TGNS or TGS in relapse after 2 treatment lines
✓. Disease progression ( previous points 4 or 5) documented by :
✓. ECOG Performance status 0-2
✓. Biological Function :
Exclusion criteria
✕. Patients whose diagnosis of relapse was not confirmed by an anatomopathological examination or by an increase of tumors markers
✕. Germ cell tumors in relapse with favorable factors of treatment response to conventional chemotherapy (RC sustainable after Cisplatin): prior cRC or incomplete clinical response but with normalization of markers and testicular origin
✕. Growing Teratoma lesions
✕. Patients with HIV infection, hepatitis B and C
✕. Patients with symptomatic brain metastases despite appropriate corticosteroid treatment
✕. Associated pathology may prevent the patient to receive treatment, creatinine clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)