Protocol

CNS831: Phase III Randomized Trial of Maintenance Chemotherapy Versus Observation in Pediatric Patients (ages 1 to 21 yrs) With Newly Diagnosed Ependymoma Following Induction Chemotherapy and Post-Operative Radiation Therapy

Diseases

Brain Tumor : Intracranial ependymoma

Description

Ependymoma is a type of cancer that occurs in the brain and spinal cord. The current standard of treatment for newly diagnosed ependymoma includes surgery to remove as much of the tumor as possible followed by radiation therapy.

Recent studies of young children have shown that chemotherapy (anti-cancer drug therapy) can help shrink or get rid of ependymoma and may make it easier for surgeons to remove the tumor.

The goal of this study is to find out if alternative treatments for ependymoma are available, including surgery followed by observation, surgery followed by chemotherapy, possible second surgery followed by radiation and chemotherapy. Patients with favorable pathology and tumor location in the upper part of the brain will undergo observation only following surgery. All other patients enrolled will receive 7 weeks of chemotherapy followed by three options depending on the results from the post induction MRI imaging (details below).

Objectives

• For patients whose tumor was completely removed by surgery with favorable pathology and tumor location (upper part of the brain) Close observation to see if they can avoid the side effects of radiation therapy without having the tumor recur
• For patients whose tumor was partially removed by surgery regardless of pathology or location: Chemotherapy (~7 weeks)
  • If no evidence of tumor on follow-up MRI and favorable location and pathology: Observation
  • If persistent tumor or new tumor in same location: Second surgery
    • If no evidence of tumor after second surgery and favorable location and pathology: Observation
    • If tumor only partially removed by second surgery regardless of location and pathology: Radiation followed by chemotherapy
• For patients with no or minimal evidence of tumor after first surgery with unfavorable pathology and location or those patients with favorable pathology and location requiring more than one surgery upfront or evidence of minimal residual disease: Randomization to radiation alone or radiation plus chemotherapy
• For patient with no evidence of disease and favorable pathology and location: Observation

In general, this study aims to determine the effects of surgery, radiation therapy and chemotherapy on learning, thinking, hearing and the production of hormones.

Eligibility

• Patient must be greater than 12 months of age and less than 21 years of age at enrollment
• Patients with newly diagnosed intracranial ependymoma without evidence of metastatic disease (confirmed by MRI brain and spine along with lumbar puncture to check CSF)
• Patients with diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are not eligible
• No prior treatment other than surgical intervention and corticosteriods
• Patient must be enrolled within 56 days of initial surgical resection

Contact

Thomas Merchant, DO,PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Phone: 901-595-3604 or 901-595-3596
FAX: 901-595-3113

Or

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.