Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01096368 : Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma
PhasePhase 3
AgesMin: 1 Year Max: 21 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01096368      |      Link to official Clinicaltrials.gov listing
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