Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer
Condition: Mediastinal Cancer; Metastatic Cancer; Testicular Germ Cell Tumor
MeSH terms: Neoplasms, Germ Cell and Embryonal; Mediastinal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining more than one drug may kill more cancer cells.
      Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and
      kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell
      transplant is more effective than chemotherapy alone.

      PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works
      when given with peripheral stem cell transplant and how it compares with combination
      chemotherapy alone in treating men with previously untreated germ cell cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of standard cisplatin, etoposide, and ifosfamide (VIP) followed by
           sequential high-dose VIP and stem cell rescue versus bleomycin, etoposide, and cisplatin
           (BEP) in men with previously untreated poor-prognosis germ cell cancer.

        -  Compare the acute and late toxicities of these treatment regimens in this patient
           population.

        -  Compare these regimens in terms of failure-free survival, response rate, and overall
           survival in these patients.

        -  Evaluate the quality of life in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, primary mediastinal germ cell tumor (yes vs no), and nonpulmonary visceral metastases
      (liver vs bone vs brain). Patients are randomized to one of two treatment arms.

        -  Arm I: Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on
           days 1-5 and bleomycin IV over 30 minutes on days 2, 8, and 15. Treatment repeats every
           3 weeks for 4 courses.

        -  Arm II: Patients receive 1 course of standard dose chemotherapy consisting of etoposide
           IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on
           days 1-5. Peripheral blood stem cells (PBSC) are harvested around day 12-15. Patients
           also receive daily filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing
           until PBSC collection is complete.

      After day 21, patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour
      followed by cisplatin IV over 1 hour, and ifosfamide IV over 1 hour on days -6 through -2.
      PBSCs are infused on day 0. Patients receive daily G-CSF subcutaneously beginning on day 1
      and continuing through day 19 or until blood counts have recovered. Treatment repeats every 3
      weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed before chemotherapy, at 6 months, and at 2 years after treatment.

      Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
      year, every 6 months for 1 year, and annually thereafter.

      PROJECTED ACCRUAL: A total of 222 patients (111 per treatment arm) will be accrued for this
      study within 2 years.
    

Intervention name(s): bleomycin sulfate; filgrastim; cisplatin; etoposide; ifosfamide; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Etoposide; Ifosfamide; Bleomycin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III malignant testicular germ cell tumor; mediastinal cancer; testicular embryonal carcinoma; testicular choriocarcinoma; testicular teratoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and seminoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor and teratoma with seminoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and seminoma; tumors metastatic to brain; liver metastases; bone metastases