Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bleomycin; Cisplatin; Etoposide; Etoposide phosphate

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