Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor

Conditions
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Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

Intervention / Treatment
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* Biological: bleomycin sulfate
* Biological: pegfilgrastim
* Drug: cisplatin
* Drug: etoposide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Patients must fulfill all of the following criteria for 1 of the following diagnoses: Nonseminoma germ cell tumor (intermediate risk) Testis or retroperitoneal primary Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN]) No liver, bone, brain, or other nonpulmonary visceral metastasis Histologic confirmation is not required if AFP or HCG are grossly elevated Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria: Mediastinal primary Nonpulmonary visceral metastases Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN) Histologic confirmation not required if AFP or HCG are grossly elevated Seminoma (intermediate prognosis) Histological confirmation is required Any primary site Nonpulmonary visceral metastases must be present Normal AFP Any HCG Any LDH Surveillance relapse Must fulfill appropriate criteria above according to initial histology PATIENT CHARACTERISTICS: Neutrophil count ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ Must have adequate renal function (creatinine clearance ≥ 60 mL/min) No prior malignancy except basal cell carcinoma PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bleomycin sulfate|nan|
|Biological: pegfilgrastim|nan|
|Drug: cisplatin|nan|
|Drug: etoposide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Feasibility |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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