COG-ACNS1123

Clinical Trial Title Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Trial Status Open to Enrollment
Start Date 11/13/2012
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Brain Cancer - Germ Cell Tumor
Description Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
Eligibility Criteria

Age:  > 3 years and < 21 years at the time of study enrollment

Diagnosis:

  • Newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2)
  • Germ cell tumors located in the suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible
  • Tumors present in the above mentioned locations and with unifocal parenchymal extension are eligible

CSF Cytology:  must have negative lumbar CSF cytology (must be obtained unless medically contraindicated)

Timing:  patients must be enrolled on ALTE07C1 (neuropsychological/behavior late effects study) prior to enrollment on ACNS1123.

Organ Function Requirement:  Adequate bone marrow, kidney, and liver function.

Central Nervous System Function:

  • Patients with seizure disorder may be enrolled if well controlled
  • Patients must not be in status, coma, or assisted ventilation prior to study enrollment

Key Exclusions Criteria:

  • Patients with mature teratoma with normal tumor markers are not eligible
  • Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible
  • Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible

 
IRB Number
Notes https://clinicaltrials.gov/ct2/show/NCT01602666
Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone 503-276-9300
Contact Fax
Contact E-Mail