Skip to Content
 

Learn More

VICC toll-free number 1-877-936-8422

Clinical Trial COGACNS0831

Title

Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years.

Principal Investigator(s)

Adam Esbenshade

Details

  • Protocol No. COGACNS0831
  • Open Date: 05/12/2011
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy with vincristine, cisplatin, etoposide and cyclophosphamide (VCEC).
  • Disease Sites: Head/Neck; Neuro-Oncology; Pediatrics
  • Therapies: Chemotherapy - cytotoxic; Radiotherapy; Surgery
  • Drugs: Carboplatin; Cisplatin; Cyclophosphamide (CTX); Etoposide; Filgrastim (GCSF); Mesna; Radiation; Vincristine
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01096368
  • Secondary Protocol No: ACNS0831

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

Ages Eligible for Study:1 Year to 21 Years
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Histologically confirmed intracranial ependymoma meeting the following criteria:
• Newly diagnosed disease
• Classic ependymoma (WHO II) or anaplastic ependymoma (WHO III), including the following subtypes:
• Clear cell
• Papillary
• Cellular
• Combination of the above
• No diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
• Has undergone surgical resection of the primary tumor
• More than 1 attempted resection allowed
• No metastatic disease by MRI or cerebrospinal fluid (CSF) cytology
• CSR cytology from a ventriculostomy or permanent VP shunt that reveals the presence of tumor cells is indicative of metastatic disease
• No evidence of non-contiguous spread beyond the primary site as determined by pre- or post-operative MRI of brain, pre- or post-operative MRI of the spine, and post-operative CSF cytology obtained from the lumbar CSF space
• Lumbar CSF examination may be waived if deemed to be medically contraindicated
• ECOG performance status (PS) 0-2
• Karnofsky PS for patients > 16 years of age
• Lansky PS for patients ≤ 16 years of age
• ANC ≥ 1,000/μL
• Platelet count ≥ 100,000/μL (transfusion independent)
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 month to < 6 months of age)
• 0.5 mg/dL (6 months to < 1 year of age)
• 0.6 mg/dL (1 to 2 years of age)
• 0.8 mg/dL (2 to < 6 years of age)
• 1.0 mg/dL (6 to 10 years of age)
• 1.2 mg/dL (10 to 13 years of age)
• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
• 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 times ULN for patients with Gilbert syndrome or hemolytic anemia)
• AST or ALT < 3 times ULN
• Adequate cardiac function defined as 1 of the following:
• Shortening fraction ≥ 27% by ECHO
• Ejection fraction ≥ 50% by gated radionuclide study.
• Not pregnant or nursing
• Patients who agree to stop nursing while on this study are allowed
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior treatment for ependymoma other than surgical intervention and corticosteroids