Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Condition: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the
      number of immune cells found in bone marrow or peripheral blood and may help the immune
      system recover from the side effects of chemotherapy. Giving combination chemotherapy
      together with pegfilgrastim may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving combination
      chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility of accelerated treatment comprising bleomycin, etoposide,
           cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.

        -  Determine the toxicity of this regimen (particularly with respect to renal, pulmonary,
           and neurological function) in these patients.

      Secondary

        -  Determine the response rate in patients treated with this regimen.

        -  Determine the progression-free survival of patients treated with this regimen.

      OUTLINE: This is a non-randomized, pilot study.

      Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV
      over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day
      4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 2 years.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): bleomycin sulfate; pegfilgrastim; cisplatin; etoposide
Intervention type(s): Biological; Biological; Drug; Drug
Intervention MeSH terms: Etoposide; Bleomycin
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: stage III malignant testicular germ cell tumor; testicular choriocarcinoma and seminoma; testicular embryonal carcinoma and seminoma; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma; testicular choriocarcinoma and yolk sac tumor; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma; testicular seminoma; testicular yolk sac tumor; testicular yolk sac tumor and teratoma with seminoma; testicular yolk sac tumor and teratoma; recurrent malignant testicular germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; adult teratoma; testicular immature teratoma; testicular mature teratoma; recurrent extragonadal germ cell tumor