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COMPLETED
NCT00864318
PHASE2

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

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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

Interventions

DRUG

Paclitaxel

200mg/m2 for 3 hours at Cycle 1 day 1 and Cycle 2 day 1 with 14 days between cycles

DRUG

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

DRUG

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

DRUG

Etoposide

From Cycle 3 to cycle 5, 400mg/m2/day from day 1 to day 3

PROCEDURE

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