Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
Sponsor: Institut Claudius Regaud
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.
Official title: Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2009-03-13
Completion Date
2020-10-05
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel
200mg/m2 for 3 hours at Cycle 1 day 1 and Cycle 2 day 1 with 14 days between cycles
Ifosfamide
2g/m²/day in 1 liter of G5 for 3 hours at Cycle 1 and Cycle 2 from day 2 to day 4 with 14 days between cycles
Carboplatine
From cycle 3 to cycle 5 : Carboplatine is administered with AUC = 24 mg/mL x min from Day 1 to Day 3. Day 3 Carboplatine dose is calculated taking into account real creatinine clearance defined at day 1 for each patient
Etoposide
From Cycle 3 to cycle 5, 400mg/m2/day from day 1 to day 3
cytapheresis + transfusion of autologous peripheral blood stem cells
Cytapheresis occured between day 11 and day 13 of the 2 first cycle (Taxol® +Holoxan®). Cytapheresis total objective is 9X106 CD34+/kg of patient weight. At cycle 3, 4 and 5 at day 5 : Re-injection of stem cells (1/3 with minimum 2.106 CD34/kg) 48 hours after chemotherapy end
Locations (12)
Centre Paul Papin
Angers, France
Hopital St André
Bordeaux, France
Institut Bergonié
Bordeaux, France
CHU
Clermont-Ferrand, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmette
Marseille, France
Institut Val d'aurelle
Montpellier, France
Centre Antoine Lacassagne
Nice, France
Hopital TENON
Paris, France
CHU
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
Institut Gustave Roussy
Villejuif, France