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| Sponsor: | Institut Claudius Regaud |
|---|---|
| Information provided by (Responsible Party): | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT00864318 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Germ Cell Tumors |
Drug: Paclitaxel Drug: Ifosfamide Drug: Carboplatine Drug: Etoposide Procedure: cytapheresis + transfusion of autologous peripheral blood stem cells |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Estimated Enrollment: | 93 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
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
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 :
progression after incomplete clinical response (Stable disease) to a Cisplatin basis chemotherapy; biomarker progression 4 weeks following the last chemotherapy cycle administration; progression during the first treatment line without obtention of at least stable disease; primitive mediastinal origin in first relapse.
Disease progression ( previous points 4 or 5) documented by :
tumors biomarkers increase (AFP and/or HCG) if no, a biopsy is needed to confirm presence of tumors active cells
Biological Function :
Neutrophils >= 1500/mm3, Platelets >= 150.000/mm3 ; normal creatinine (or clearance >= 50 ml/mn) ; SGOT, SGPT <= 2,5N (or 5N if hepatic metastases), Bilirubin < 1,5N
Exclusion Criteria:
Contacts and Locations| Contact: Christine CHEVREAU, MD | +33 5 61 42 42 42 | Chevreau.Christine@claudiusregaud.fr |
| Contact: Muriel POUBLANC | + 33 5 61 42 46 74 | Poublanc.Muriel@claudiusregaud.fr |
| France | |
| Centre Paul Papin | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Rémy DELVA, MD r.delva@unimedia.fr | |
| Principal Investigator: Rémy DELVA, MD | |
| Institut Bergonié | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: Binh BUI, MD bui@bergonie.org | |
| Principal Investigator: Binh BUI, MD | |
| Hopital St André | Not yet recruiting |
| Bordeaux, France, 33075 | |
| Contact: Alain RAVAUD, MD alain.ravaud@chu-bordeaux.fr | |
| Principal Investigator: Alain RAVAUD, MD | |
| CHU | Not yet recruiting |
| Clermont Ferrand, France, 63003 | |
| Contact: Jacques-Olivier BAY, MD jobay@chu-clermontferrand.fr | |
| Principal Investigator: Jacques-olivier BAY, MD | |
| hopital Mondor | Not yet recruiting |
| Créteil, France, 94010 | |
| Contact: Stéphane CULINE, MD stephane.culine@hmn.aphp.fr | |
| Principal Investigator: Stéphane CULINE, MD | |
| Center Oscar Lambret | Not yet recruiting |
| Lille, France, 59020 | |
| Contact: Armelle CATY, MD a-caty@o-lambret.fr | |
| Principal Investigator: Armelle CATY, MD | |
| Centre Léon Bérard | Not yet recruiting |
| Lyon, France, 69373 | |
| Contact: Aude FLECHON, MD flechon@lyon.fnclcc.fr | |
| Principal Investigator: Aude FLECHON, MD | |
| Institut Paoli Calmette | Not yet recruiting |
| Marseille, France, 13273 | |
| Contact: Gwenaëlle GRAVIS, MD gravisg@marseille.fnclcc.fr | |
| Principal Investigator: Gwenaelle GRAVIS, MD | |
| Institut Val d'aurelle | Not yet recruiting |
| Montpellier, France, 34298 | |
| Contact: Damien POUESSEL, MD damien.pouessel@valdorel.fnclc.fr | |
| Principal Investigator: Damien POUESSEL, MD | |
| Centre Antoine Lacassagne | Not yet recruiting |
| Nice, France, 06050 | |
| Contact: Antoine THYSS, MD antoine.thyss@cal.nice.fnclcc.fr | |
| Principal Investigator: Antoine THYSS, MD | |
| Hopital TENON | Not yet recruiting |
| Paris, France, 75970 | |
| Contact: Jean-Pierre Lotz, MD jean-pierre.lotz@tnn.aphp.fr | |
| Principal Investigator: Jean-Pierre LOTZ, MD | |
| CHU | Not yet recruiting |
| Strasbourg, France, 67091 | |
| Contact: Brigitte DUCLOS, MD brigitte.duclos@chur-strasbourg.fr | |
| Principal Investigator: Brigitte DUCLOS, MD | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Christine Chevreau, MD +33 5.59.42.41.18 Chevreau.Christine@claudiusregaud.fr | |
| Principal Investigator: Christine CHEVREAU, MD | |
| IGR | Not yet recruiting |
| Villejuif, France, 94805 | |
| Contact: Karim FIZAZI, MD karim.fizazi@igr.fr | |
| Principal Investigator: Karim FIZAZI, MD | |
| Principal Investigator: | Christine CHEVREAU, MD | Institut Claudius Regaud |
More Information
| Responsible Party: | Institut Claudius Regaud |
| ClinicalTrials.gov Identifier: | NCT00864318 History of Changes |
| Other Study ID Numbers: | 08 GENH 06 |
| Study First Received: | March 16, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
refractory germ cell tumors relapse bad prognosis Refractory germ cell tumors with relapse and bad prognosis |
|
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Etoposide Paclitaxel Etoposide phosphate Isophosphamide mustard Ifosfamide Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators |