Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
Condition: Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Teratoma
Study type: Interventional
Phase: Phase 2

Summary: 
      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 the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with bone marrow transplantation or peripheral stem cell transplantation works in treating
      patients with relapsed germ cell cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with
           autologous stem cell rescue in patients with relapsed germ cell cancer.

        -  Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem
           cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support
           in these patients.

      OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem
      cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells
      cannot be collected.

      Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel
      IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and
      carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a
      second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours,
      then CBDCA and ifosfamide on days -6 to -4.

      Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV
      is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3
      are maintained. On day 0, stem cells with or without bone marrow product are again
      administered.

      Surgery may be performed after course 2 if indicated.

      PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
    

Intervention name(s): filgrastim; carboplatin; etoposide; ifosfamide; paclitaxel; autologous bone marrow transplantation; bone marrow ablation with stem cell support
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): 5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.; AUC=7, daily X 3; 20 mg/kg by 2 hours infusion daily X 3; 3 gm/m2 IV over 30 minutes X 3 days; 425 mg/m2 as 24 hour continuous infusion; Given in two divided infusions on day -2 and day 0; Two cycles of high dose chemotherapy followed by stem cell reinfusion
Intervention MeSH terms: Paclitaxel; Etoposide; Carboplatin; Ifosfamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent malignant testicular germ cell tumor; testicular seminoma; testicular embryonal carcinoma; testicular choriocarcinoma; 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; recurrent ovarian germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; recurrent extragonadal germ cell tumor; adult teratoma; testicular immature teratoma; testicular mature teratoma; ovarian immature teratoma; ovarian mature teratoma; ovarian monodermal and highly specialized teratoma; stage III malignant testicular germ cell tumor; stage IV ovarian germ cell tumor; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; adult central nervous system germ cell tumor