Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
Condition: Extragonadal Germ Cell Tumor; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not known whether combining chemotherapy with bone marrow
      transplantation is a more effective treatment for men with germ cell tumors.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with bone marrow transplantation in treating men with relapsed germ cell tumors.
    

Detailed description: 
      OBJECTIVES: I. Compare the event-free survival of male patients with germ cell tumors in
      relapse or first partial remission treated with salvage therapy comprising cisplatin,
      etoposide, and ifosfamide (PEI) or vinblastine, ifosfamide, and cisplatin (VeIP) with or
      without high-dose carboplatin, etoposide, and cyclophosphamide, followed by autologous bone
      marrow and/or peripheral blood stem cell transplantation.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
      complete remission to first-line treatment (yes vs no), primary site of disease (testicular
      vs retroperitoneal vs mediastinal), and lung metastases at study entry (yes vs no).
      Autologous bone marrow and peripheral blood stem cells (PBSC) are harvested. Part I
      (salvage): Patients are assigned to regimen A if they previously received vinblastine as part
      of a first-line treatment, such as cisplatin, vinblastine, and bleomycin (PVB) or cisplatin,
      cyclophosphamide, doxorubicin, vinblastine, and bleomycin (CISCA VB). Patients are assigned
      to regimen B if they previously received etoposide (VP-16) as part of a first-line treatment,
      such as bleomycin, VP-16, and cisplatin (BEP). Regimen A: Patients receive cisplatin IV over
      2 hours, VP-16 IV over 2 hours, and ifosfamide IV over 1 hour on days 1-5 (PEI). Regimen B:
      Patients receive cisplatin and etoposide as in regimen A and vinblastine IV on days 1 and 2
      (VeIP). Treatment on both regimens continues every 3 weeks for 2 courses. Patients with
      refractory disease at day 43 are taken off study. Part II: Patients are randomized to 1 of 2
      treatment arms. Arm I: Patients receive 2 additional courses of PEI or VeIP. Arm II: Patients
      receive 1 additional course of PEI or VeIP, followed by 1 course of high-dose carboplatin IV
      over 2 hours, VP-16 IV over 2 hours, and cyclophosphamide IV over 1 hour on days 1-4.
      Autologous bone marrow and/or PBSC are reinfused on day 7 of the fourth course for patients
      on both arms. Patients on both arms with residual disease after the fourth course may undergo
      surgery.

      PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
    

Intervention name(s): carboplatin; cisplatin; cyclophosphamide; etoposide; ifosfamide; vinblastine sulfate; autologous bone marrow transplantation; conventional surgery; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Ifosfamide; Carboplatin; Etoposide; Vinblastine
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent malignant testicular germ cell tumor; extragonadal germ cell tumor