Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT04408092
Eligibility Criteria:
Inclusion Criteria:
* Age \> 12 months and \< 21 years at the time of study enrollment.
* Patients must be one of the following:
• Newly diagnosed with posterior fossa ependymoma with a subtotal resection at initial surgery. These patients will be eligible for stratum 1.
* Be in first relapse of their posterior fossa ependymoma. These patients will be eligible for stratum 2.
* Histologically confirmed diagnosis of intracranial ependymoma .
* Pre or post-operative MR imaging of the brain demonstrates no evidence of non-contiguous spread beyond the primary site
* Pre or post-operative MR imaging of the spine demonstrates no evidence of non-contiguous spread beyond the primary site
* Pre-operative CSF cytology obtained from the lumbar CSF space demonstrated no evidence of non-contiguous spread beyond the primary site.
• The requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated.
* Patients must meet one of the following performance scores.
• ECOG performance status scores of 0, 1, or 2.
* Karnofsky score of ≥ 50 for patients \> 16 years of age or Lansky score of ≥ 50 for patients ≤ 16 years of age
* Organ Function Requirements:
Adequate renal function defined as:
* Creatinine clearance or radioisotope GFR ³ 70ml/min/1.73 m2 or
* A serum creatinine based on age/gender as follows:
Age Maximum Serum Creatinine (mg/dL) Male Female
1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5
1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
≥ 16 years 1.7 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.
* Adequate liver function defined as:
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age.
* Patients with Gilbert syndrome or hemolytic anemia are eligible if total bilirubin is \< 3 x upper limit of normal (ULN) for age.
* Adequate Bone Marrow Function defined as:
* Peripheral absolute neutrophil count (ANC) \>= 1,000/uL
* Platelet count \>= 100,000/uL (transfusion independent).
Exclusion Criteria:
* Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, supratentorial ependymoma, or mixed glioma are NOT eligible.
* Patients with evidence of metastatic disease by MRI or CSF cytology are NOT eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
21 Years
Study:
NCT04408092
Study Brief:
Protocol Section:
NCT04408092