RecruitingBasal Ganglia GerminomaDiabetes InsipidusGerminoma

A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma

Eligible age

3–29 yrs

Accepts

All genders

Locations

42 states

Healthy volunteers

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About this study

This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.

Sponsor: Children's Oncology Group

You may qualify if…

✓ Patients must be ≥ 3 years and \< 30 years at the time of study enrollment
✓ Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required
✓ Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required
✓ Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required
✓ Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible
✓ Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible
✓ Patients with germinoma admixed with mature teratoma are eligible
✓ Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age

You may not qualify if…

✕ Patients with any of the following malignant pathological elements are not eligible:
✕ Endodermal sinus (yolk sac)
✕ Embryonal carcinoma, choriocarcinoma
✕ Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)
✕ Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible
✕ Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible
✕ Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
✕ Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards