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Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors (NCT00003852)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy.
  • Biological: filgrastim
    • Drug: carboplatin
      • Drug: cyclophosphamide
        • Drug: epirubicin hydrochloride
          • Drug: etoposide
            • Drug: ifosfamide
              • Drug: paclitaxel
                • Drug: thiotepa
                  • Procedure: bone marrow ablation with stem cell support
                    • Procedure: peripheral blood stem cell transplantation
                      Ages eligible for Study
                      15 Years to 120 Years
                      Genders eligible for Study
                      All
                      Accepts Healthy Volunteers
                      No
                      OBJECTIVES: I. Determine the complete response rate (chemotherapy complete response, pathological complete response, or surgical complete response) to intensive chemotherapy with autologous peripheral blood stem cell support in patients with cisplatin resistant germ cell tumors. II. Determine duration of complete response and survival of these patients after this therapy. III. Determine the toxic effects of this regimen in these patients. IV. Determine the pharmacokinetics of this regimen and the relationship between these pharmacokinetics, nature and duration of response to treatment, and the toxic effects in these patients.

                      OUTLINE: This is an open label, multicenter study. Patients receive epirubicin IV over 15 minutes and paclitaxel IV over 3 hours on day 1, then filgrastim (G-CSF) subcutaneously (SQ) on days 5-14. Peripheral blood stem cells (PBSC) are collected on days 13 and 14. This course is repeated beginning on day 15. Patients then undergo a three part intensification regimen. Part I: Patients receive cyclophosphamide IV and thiotepa IV by continuous infusion on days 34 and 35. PBSC are reinfused on day 38, and G-CSF SQ is administered from day 39 until blood cell counts recover. Part II: Patients receive etoposide IV over 2 hours, ifosfamide IV over 4 hours, and carboplatin IV over 6 hours on days 62-66. PBSC are reinfused on day 70, and eventually G-CSF begins on day 71. Part III: Patients receive etoposide, ifosfamide, and carboplatin on days 90-94 as in part II. PBSC are reinfused on day 98 and eventually G-CSF begins on day 99. Patients are followed every month for the first year, every 2 months for the second year, every 6 months for the third and fourth years, then annually thereafter.

                      PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 2 years.

                      18 locations

                      France (18)
                      • Centre Paul Papin
                        Angers, France, 49036
                      • CHR de Besancon - Hopital Jean Minjoz
                        Besancon, France, 25030
                      • Institut Bergonie
                        Bordeaux, France, 33076
                      • Centre Regional Francois Baclesse
                        Caen, France, 14076
                      • Centre Jean Perrin
                        Clermont-Ferrand, France, 63011
                      • Centre de Lute Contre le Cancer,Georges-Francois Leclerc
                        Dijon, France, 21079
                      • CHR de Grenoble - La Tronche
                        Grenoble, France, 38043
                      • Clinique Saint Michel
                        La Rochelle, France, 17000
                      • Centre Leon Berard
                        Lyon, France, 69373
                      • Institut J. Paoli and I. Calmettes
                        Marseille, France, 13273
                      • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
                        Montpellier, France, 34298
                      • Centre Antoine Lacassagne
                        Nice, France, 06189
                      • Hopital d'Instruction des Armees du Val de Grace
                        Paris, France
                      • Institut Jean Godinot
                        Reims, France, 51056
                      • Centre Henri Becquerel
                        Rouen, France, 76038
                      • Centre Rene Huguenin
                        Saint Cloud, France, 92211
                      • Hopitaux Universitaire de Strasbourg
                        Strasbourg, France, 67091
                      • Institut Gustave Roussy
                        Villejuif, France, F-94805
                      Status:
                      terminated
                      Type:
                      Interventional
                      Phase:
                      Start:
                      28 February, 1998
                      Updated:
                      21 June, 2016
                      Participants:
                      45
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