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
Intervention: filgrastim; carboplatin; etoposide; ifosfamide; paclitaxel; autologous bone marrow transplantation; bone marrow ablation with stem cell support
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 16 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker
             elevation) and not curable by standard salvage therapy OR viable cancer on resection
             of post-chemotherapy residual masses in either intermediate or high risk category

          -  Bidimensionally measurable disease with measurements performed within 21 days of study
             entry

          -  Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic
             gonadotropin) studies performed within 7 days prior to study entry

        PATIENT CHARACTERISTICS:

        Age:

          -  16 and over

        Performance status:

          -  Karnofsky 70-100%

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 120,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic:

          -  Bilirubin no greater than 1.6 mg/dL

          -  SGOT and SGPT no greater than 2 times upper limit of normal (ULN)

          -  No active hepatitis or cirrhosis

        Renal:

          -  Creatinine clearance at least 70 mL/min

        Cardiovascular:

          -  Ejection fraction (MUGA or echocardiogram) normal

          -  No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would
             contraindicate etoposide and paclitaxel study treatment

        Pulmonary:

          -  PaO_2 at least 70 mm Hg

          -  FEV_1 at least 2 L or 75%

          -  No history of bleomycin associated or serious lung disease

        Neurologic:

          -  No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at
             least 1 month with stable post-radiotherapy neurological status and seizure free; if
             prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study

          -  Prior peripheral neuropathy requires consultation with principal investigator

        Other:

          -  No significant active medical illness precluding study or survival

          -  Not HIV positive

          -  No prior malignancy within past 5 years except for adequately treated basal cell or
             squamous cell skin cancer

          -  No prior hematologic malignancies

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior bone marrow or stem cell rescue with high-dose chemotherapy

        Chemotherapy:

          -  Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell
             rescue

          -  No prior paclitaxel

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No concurrent radiotherapy during study

        Surgery:

          -  Recovered from prior surgery