Current Research: Pediatric Hematology-Oncology

AGCT0132 – Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediaate Risk Extracranial Germ Cell Tumors

The purpose of this research study is to study 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

Patients may be eligible for this trial if:

• The patient is 21 years of age or less at diagnosis, except patients with testicular primary tumors, who must be less than 15 years of age.
• The patient has Stage I-IV malignant testicular germ cell tumors, Stage I-III malignant ovarian germ cell tumors or Stage I-II malignant extragonadal germ cell tumors.
• Tumor markers (alpha-fetoprotein (AFP) and beta human chorionic gonadotropin must be obtained prior to study entry.
• Serum creatinine is normal for the patient’s age. (If serum creatinine is abnormal for age, the patient will be eligible if isotope GFR > 50% normal or creatinine clearance > 60 ml/min/1.73 m2.)
• The patient has not received any previous chemotherapy or radiation therapy.
• The patient must be registered within three weeks of original diagnostic surgery.

Trial Sponsor

• Children’s Oncology Group (COG)

Project Begin Date

• Sept 2005

Tentative Project End Date

• Oct 2010

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .