At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed intracranial NGGCT of one of the following types: endodermal sinus tumor, embryonal carcinoma, choriocarcinoma, immature teratoma, teratoma with malignant transformation, or mixed germ cell tumor
- ✓Histologically confirmed germinoma with serum or CSF beta-HCG >50 mIU/mL or serum or CSF AFP >10 ng/mL or above institutional norm
- ✓Histologically unconfirmed pineal and/or suprasellar tumors with serum or CSF beta-HCG >50 mIU/mL or AFP >10 ng/mL or above institutional norm
- ✓Age 3 to 24 years at diagnosis
- ✕Patients with normal AFP and beta-HCG <50 mIU/mL without histologic diagnosis of NGGCT
- ✕Pure germinoma without elevation of tumor markers
- ✕Patients in status epilepticus or coma
- ✕Pregnancy or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT
In Brief
A Phase 2 clinical trial evaluating carboplatin, etoposide, and 7 other interventions for Brain Tumor and 2 related conditions. Completed, enrolled 104 participants across 106 sites in 5 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells. PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given IV
craniospinal irradiation