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Brief Title: Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma
Official Title: A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease
Study ID: NCT00025636
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: * Compare the efficacy of induction chemotherapy followed by combination chemotherapy and autologous peripheral blood stem cell transplantation with or without high-dose sequential chemotherapy in terms of freedom from treatment failure in patients with relapsed Hodgkin's lymphoma. * Compare the toxicity of these regimens in these patients. * Compare the complete remission/unconfirmed complete remission rate at 3 months, relapse-free survival, and overall survival of patients treated with these regimens. * Compare the frequency of severe toxic effects and secondary neoplasia in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse \[remission duration 3-12 months\] vs late first relapse \[remission duration more than 12 months\] vs second relapse without prior high-dose chemotherapy salvage \[remission duration after salvage at least 3 months\]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change). All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms. * Arm I: Patients receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 37 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 37-40. Patients also receive G-CSF SC twice daily beginning on day 41 and continuing until blood counts recover. Autologous peripheral blood stem cells (PBSCs) are reinfused on day 42. * Arm II: Patients receive high-dose cyclophosphamide IV over 8 hours on day 37, high-dose methotrexate IV over 6 hours and high-dose vincristine IV on day 51, and high-dose etoposide IV over 8 hours on days 58-61. Patients then receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 80 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 80-83. Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover. Autologous PBSCs are reinfused on day 85. Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy. Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Algemeen Ziekenhuis Sint Lucas, Ghent, , Belgium
University Hospital Rebro, Zagreb, , Croatia
Rigshospitalet - Copenhagen University Hospital, Copenhagen, , Denmark
Charite - Campus Charite Mitte, Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Charite - Campus Virchow Klinikum, Berlin, , Germany
Medizinische Poliklinik, Bonn, , Germany
Medizinische Universitaetsklinik I at the University of Cologne, Cologne, , Germany
Staedtisches Klinikum Dessau, Dessau, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Evangelisches Krankenhaus Essen Werden, Essen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Martin Luther Universitaet, Halle, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Evangelische Krankenhaus Hamm, Hamm, , Germany
Krankenhaus Siloah - Medizinische Klinik II, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Medizinische Universitaetsklinik und Poliklinik, Heidelberg, , Germany
St. Bernward Krankenhaus, Hildeshem, , Germany
Universitaetsklinikum des Saarlandes, Homburg, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology, Idar-Oberstein, , Germany
Klinikum der Friedrich-Schiller Universitaet Jena, Jena, , Germany
Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Luebeck, , Germany
Krankenhaus Muenchen Schwabing, Munich, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, , Germany
Diakonie Klinikum Stuttgart, Stuttgart, , Germany
Dr. Horst-Schmidt-Kliniken, Wiesbaden, , Germany
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, , Netherlands
Maxima Medisch Centrum - Veldhoven, Veldhoven, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Name: Andreas Engert, MD
Affiliation: Medizinische Universitaetsklinik I at the University of Cologne
Role:
Name: J. W. Baars, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role:
Name: Norbert Schmitz, MD, PhD
Affiliation: Asklepios Klinik St. Georg
Role: