Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
Condition: Childhood Embryonal Tumor; Childhood Extracranial Germ Cell Tumor; Childhood Extragonadal Germ Cell Tumor; Childhood Malignant Ovarian Germ Cell Tumor; Childhood Malignant Testicular Germ Cell Tumor; Childhood Teratoma; Ovarian Embryonal Carcinoma; Ovarian Yolk Sac Tumor; Stage II Malignant Testicular Germ Cell Tumor; Stage IIA Ovarian Germ Cell Tumor; Stage IIB Ovarian Germ Cell Tumor; Stage IIC Ovarian Germ Cell Tumor; Stage III Malignant Testicular Germ Cell Tumor; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIC Ovarian Germ Cell Tumor; Testicular Choriocarcinoma and Yolk Sac Tumor; Testicular Embryonal Carcinoma
MeSH terms: Carcinoma; Neoplasms; Neoplasms, Germ Cell and Embryonal; Germinoma; Ovarian Neoplasms; Teratoma; Testicular Neoplasms; Carcinoma, Embryonal; Endodermal Sinus Tumor; Choriocarcinoma
Intervention: conventional surgery; cisplatin; etoposide; bleomycin sulfate; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Etoposide; Etoposide phosphate; Bleomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying surgery followed by combination chemotherapy to see how well
      it works in treating children with germ cell tumors that are not located in the head. Drugs
      used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. Combining more than one drug, and giving them after surgery, may kill any
      remaining tumor cells following surgery. It is not yet known whether combination chemotherapy
      is effective in decreasing the recurrence of childhood germ cell tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Extracranial germ cell tumor that contains 1 of the following malignant histologies:
             NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible
             provided 1 of the 3 histologies listed above is also present in the tumor.

               -  Yolk sac tumor

               -  Embryonal carcinoma

               -  Choriocarcinoma

          -  Low-risk disease (closed to accrual as of 01/20/10)

               -  Stage I gonadal tumors (ovarian and testicular)

               -  Must have undergone complete surgical and radiologic staging to exclude the
                  possibility of > stage I disease

          -  Intermediate-risk disease

               -  Stage II, III, or IV malignant testicular GCT

               -  Stage II or III malignant ovarian GCT

               -  Stage I or II malignant extragonadal GCT

               -  Previously stage I gonadal patients who have relapsed on the low-risk
                  (observation) stratum of this study(closed to accrual as of 01/20/10)

               -  Patients with immature teratoma or mature teratoma who relapse with a malignant
                  component

          -  No patients with any of the following diagnoses:

               -  Stage IV ovarian and stage III-IV extragonadal GCT

               -  Intracranial GCT

               -  Pure mature or immature teratoma, pure dysgerminoma, or seminoma

               -  Patients with a non-germ cell component in their GCT (e.g., primitive
                  neuroectodermal tumors or rhabdomyosarcoma)

          -  Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known

               -  If > 5 days have elapsed from the time of obtaining original markers, tumor
                  markers must be repeated before enrollment of low-risk patients and before
                  initiating therapy in intermediate-risk patients (the results of the repeated
                  tumor markers do not have to be known at the time of study enrollment)

          -  Must be enrolled within 6 weeks of original diagnostic surgery

          -  Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on
             age/gender as follows:

               -  ≤ 0.4 mg/dL (for patients 1 to 5 months of age)

               -  ≤ 0.5 mg/dL (for patients 6 to 11 months of age)

               -  ≤ 0.6 mg/dL (for patients 1 year of age)

               -  ≤ 0.8 mg/dL (for patients 2 to 5 years of age)

               -  ≤ 1.0 mg/dL (for patients 6 to 9 years of age)

               -  ≤ 1.2 mg/dL (for patients 10 to 12 years of age)

               -  ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)

               -  ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)

               -  ≤ 1.7 mg/dL (for male patients ≥ 16 years of age)

          -  No prior chemotherapy

          -  No prior radiotherapy