COG-ACNS0831
| Clinical Trial Title | Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma |
| Trial Status | Open to Enrollment |
| Start Date | 08/02/2012 |
| Location | randall-childrens-hospital-at-legacy-emanuel |
| Trial Type | Pediatric Cancer (Oncology) |
| Specific Condition | Ependymoma |
| Description | This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started. |
| Eligibility Criteria | Patients must be enrolled on COG Study ACNS0831 within 56 days of initial surgical resection at which time tissue is acquired to determine a diagnosis Mandatory submission of pre and post operative brain and total spine MR for central review Mandatory submission of tissue samples for central pathology review or rapid central pathology review (for supratentorial primary site) Age: >12 months and <21 years of age at the time of study enrollment Newly diagnosed with intracranial ependymoma including classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) Various subtypes described as clear cell, papillary, cellular, or a combination of the above are also eligible Diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are not eligible Patients with evidence of metastatic disease by MRI or CSF cytology are not eligible No prior treatment other than surgical intervention and corticosteroids Patients are allowed to have had more than one attempt at resection prior to enrollment Adequate kidney, liver, heart, and bone marrow function |
| IRB Number | |
| Notes | https://clinicaltrials.gov/ct2/show/NCT01096368 |
| Principal Investigator | Janice Olson, MD |
| Contact Name | Children's Cancer and Blood Disorders Program |
| Contact Phone | (503) 276-9300 |
| Contact Fax | |
| Contact E-Mail |
