Clinical Trial Title Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
Trial Status Closed to Enrollment
Start Date 03/24/2011
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Medulloblastoma (Recurrent / Refractory)
Description This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.
Eligibility Criteria Age: must be no greater than 21 years of age at the time of study enrollment

Diagnosis: medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy

Patients with pineoblastoma are eligible

Must have had histologic verification of malignancy at original diagnosis or at the time of recurrence

Must have measurable residual disease; diffuse leptomeningeal disease is not considered measurable

Life expectancy: >8 weeks

Patients must have experienced at least one and at most two relapses prior to study enrollment

Patients with primary refractory disease are eligible

Patients must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

Patients must have recovered from any surgical procedure before enrolling on this study (lumbar punctures or placement of PICC lines are acceptable at any time prior or during therapy)

Hypertension must be well controlled

Adequate bone marrow, kidney, liver, and coagulation function

Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants
IRB Number

Study status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Principal Investigator Janice Olson, MD
Contact Name Children's Cancer and Blood Disorders Program
Contact Phone (503) 276-9300
Contact Fax
Contact E-Mail