Salvage Chemotherapy for Poor Prognosis Germ Cell Tumors - Trial NCT01966913
Access comprehensive clinical trial information for NCT01966913 through Pure Global AI's free database. This Early Phase 1 trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently status unknown. The study focuses on Germ Cell Tumor. Target enrollment is 30 participants.
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Study Focus
Sponsor & Location
Assistance Publique - Hôpitaux de Paris
Timeline & Enrollment
Early Phase 1
Apr 01, 2012
Sep 01, 2020
Primary Outcome
Response,Toxicity
Summary
High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard
 salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).
 
 Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/-
 ifosfamide depends on the patient's performance status (PS) at inclusion and the prior
 sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin
 suggest a higher toxicity and a bad prognosis.
 
 However, predictive factors of response to high-dose chemotherapy do not include a
 chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound
 (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this chemotherapy
 combination induced a response in more than one third of the patients treated during disease
 progression in the TAXIF I study. The same strategy was tested in the TAXIF II study, which
 completed the inclusion of 45 patients and was closed in May 2008. Results of the TAXIF II
 study, are currently being analyzed; they support the hypothesis to prioritarily treat
 patients with a sensitive relapsed disease at the time of the high-dose administration.
 
 A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used
 on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed, the
 overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an
 independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy
 using an inductive chemotherapy followed, in case of response, by a double intensification
 therapy in combination with a VEGF treatment, could be an interesting approach in patients
 with poor prognosis germ cell tumors.
 
 The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE
 (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous
 hematopoietic stem cell for two intensive consecutive cycles (tandem intensification) in
 patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization
 chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT01966913
Non-Device Trial