Overview

Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

Status:
Completed
Trial end date:
2020-10-05
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Institut Claudius Regaud
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Paclitaxel