Skip to Content

Vanderbilt-Ingram Cancer CenterVanderbilt-Ingram Cancer Center

 

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
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01096368
  • Secondary Protocol No: ACNS0831

Description

None Provided.

Eligibility

Ages Eligible for Study:1 Year to 21 Years
Genders Eligible for Study:Both
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