Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
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: pegfilgrastim; cisplatin; ifosfamide; paclitaxel
Intervention MeSH terms: Paclitaxel; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II malignant testicular germ cell tumor; stage III malignant testicular germ cell tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and seminoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma; testicular embryonal carcinoma and seminoma; 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 and teratoma with seminoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor; stage I malignant testicular germ cell tumor; adult central nervous system germ cell tumor; ovarian choriocarcinoma; ovarian dysgerminoma; ovarian embryonal carcinoma; ovarian yolk sac tumor; ovarian immature teratoma; ovarian mature teratoma; ovarian monodermal and highly specialized teratoma; ovarian polyembryoma; ovarian mixed germ cell tumor; stage IV ovarian germ cell tumor; stage IV extragonadal seminoma; stage I extragonadal non-seminomatous germ cell tumor; stage II extragonadal non-seminomatous germ cell tumor; stage III extragonadal non-seminomatous germ cell tumor; stage IV extragonadal non-seminomatous germ cell tumor; adult teratoma; testicular immature teratoma; testicular mature teratoma; stage IA ovarian germ cell tumor; stage IB ovarian germ cell tumor; stage IC ovarian germ cell tumor; stage IIA ovarian germ cell tumor; stage IIB ovarian germ cell tumor; stage IIC ovarian germ cell tumor; stage IIIA ovarian germ cell tumor; stage IIIB ovarian germ cell tumor; stage IIIC ovarian germ cell tumor

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
      cells. 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.

      PURPOSE: This phase II trial is studying the side effects and how well giving combination
      chemotherapy together with pegfilgrastim works in treating patients with previously untreated
      germ cell tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed germ cell tumor meeting 1 of the following criteria:

               -  Poor risk, defined by any of the following:

                    -  Testis or retroperitoneal primary site nonseminoma histology without
                       visceral metastases but with "poor-risk" markers, defined by any of the
                       following:

                         -  Pretreatment serum lactate dehydrogenase (LDH) > 10 times upper limit
                            of normal (ULN)

                         -  Pretreatment serum human chorionic gonadotropin (HCG) > 50,000 IU/L

                         -  Pretreatment serum alpha fetoprotein (AFP) > 10,000 ng/mL

                    -  Testis or retroperitoneal primary site nonseminoma histology with one or
                       more nonpulmonary visceral metastases, including any of the following
                       (regardless of serum tumor marker values):

                         -  Bone metastases

                         -  Brain metastases

                         -  Hepatic metastases

                         -  Any nonpulmonary metastases (i.e., skin, spleen)

                    -  Mediastinal primary site nonseminoma histology regardless of serum tumor
                       marker levels or presence/absence of visceral metastases

               -  Modified intermediate risk, defined by any of the following:

                    -  Testis or retroperitoneal primary site nonseminoma histology with no
                       nonpulmonary visceral metastases, and with any of the following serum marker
                       values:

                         -  Pretreatment serum LDH 3.0-10 times ULN

                         -  Pretreatment serum HCG 5,000-50,000 IU/L

                         -  Pretreatment serum AFP 1,000-10,000 ng/mL

                    -  Seminoma histology with one or more nonpulmonary visceral metastases,
                       including any of the following (regardless of serum tumor marker values or
                       primary site):

                         -  Bone metastases

                         -  Brain metastases

                         -  Hepatic metastases

                         -  Any nonpulmonary visceral metastases (i.e., skin, spleen)

          -  Previously untreated disease

          -  Measurable or evaluable disease

        PATIENT CHARACTERISTICS:

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine normal or creatinine clearance > 50 mL/min (unless renal dysfunction is due
             to tumor obstructing the ureters)

          -  AST and ALT ≤ 3 times ULN

          -  Bilirubin ≤ 2.0 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No concurrent malignancy except for nonmelanoma skin cancer

          -  No known HIV positivity

          -  No active infections

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior surgery

          -  More than 30 days since prior radiotherapy and recovered (unless evidence of
             progressive disease has been documented)

          -  No prior chemotherapy

          -  No other concurrent cytotoxic therapy

          -  Concurrent radiotherapy and surgery allowed for treatment of brain metastases