Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

This partially 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, by stopping them from dividing, or by stopping them from spreading. 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Radiation: 3-Dimensional Conformal Radiation Therapy
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Other: Clinical Observation
  • Drug: Cyclophosphamide
  • Drug: Etoposide
  • Other: Laboratory Biomarker Analysis
  • Drug: Vincristine Sulfate Liposome

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must be newly diagnosed with histologically confirmed intracranial
   ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO
   III) are eligible, as are various subtypes described as clear cell, papillary,
   cellular or a combination of the above

   - There is no minimum performance level; children with ependymoma may suffer neurologic
   sequelae as a result of their tumor or surgical measures taken to establish a
   diagnosis and resect the tumor; in the majority of cases, there is neurologic
   recovery; neurologic recovery is not likely to be impeded by protocol therapy

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with evidence of metastatic disease will be excluded; any evidence of
   non-contiguous spread beyond the primary site as determined by pre or post-operative
   magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the
   spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar
   CSF space (the requirement for lumbar CSF examination may be waived if deemed to be
   medically contraindicated); CSF cytology from a ventriculostomy or permanent
   ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative
   of metastatic disease

   - Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma,
   subependymoma, ependymoblastoma, or mixed glioma 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

   - Pregnant female patients are not eligible for this study

   - Post-menarchal females may not participate unless a pregnancy test with a negative
   result has been obtained

   - Males and females of reproductive potential may not participate unless they have
   agreed to use an effective contraceptive method

   - Lactating females may not participate unless they have agreed not to breastfeed a
   child while on this study

Ages Eligible for Study

13 Months - 20 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leah White
650-725-4708
Recruiting

Pediatric Trials