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

Completed · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00053352

Run by

Children's Oncology Group

People needed

302

Starts

2003-11-03

Expected to finish

2021-06-30

Last updated by the study team

2021-07-13

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter General Hospital — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Healthcare System - Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.