Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
Condition: Anaplastic Ependymoma; Brain Ependymoma; Cellular Ependymoma; Clear Cell Ependymoma; Ependymoma; Papillary Ependymoma
MeSH terms: Ependymoma
Intervention: 3-Dimensional Conformal Radiation Therapy; Carboplatin; Cisplatin; Clinical Observation; Cyclophosphamide; Etoposide; Filgrastim; Laboratory Biomarker Analysis; Mesna; Vincristine
Intervention description: Patients undergo conformal radiotherapy; Given IV; Given IV; Patients undergo observation; Given IV; Given IV; Given SC or IV; Optional correlative studies; Given IV; Given IV
Intervention MeSH terms: Cyclophosphamide; Cisplatin; Carboplatin; Etoposide; Vincristine; Etoposide phosphate; Podophyllotoxin; Lenograstim; Mesna
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 479.0
Sex: All
Minimum age: 12 Months
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The primary aim of this randomized phase III trial was to study whether the addition of
      maintenance chemotherapy delivered after surgical resection and focal radiation would be
      better than surgery and focal radiation alone. The trial also studied if patients who
      received induction chemotherapy and then either achieved a complete response or went on to
      have a complete resection would also benefit from maintenance chemotherapy. Children ages
      1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that
      were not randomized. One arm studied patients with Grade II tumors located in the
      supratentorial compartment that were completely resected. One arm studied patients with
      residual tumor and those patients all received maintenance chemotherapy after focal
      radiation. Chemotherapy drugs, 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 in combination with radiation therapy may kill more
      tumor cells and allow doctors to save the part of the body where the cancer started.
    

Eligibility criteria:

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