At a glance
ClinicalIndex Comparison Record- ✓Ages 1 to 21 years
- ✓Histologically confirmed intracranial ependymoma (differentiated or anaplastic)
- ✓Initial surgical resection within the past 56 days
- ✓Able to undergo MRI
- ✕Primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
- ✕Evidence of noncontiguous spread beyond primary site
- ✕Prior chemotherapy
- ✕Prior radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma
In Brief
A Phase 2 clinical trial evaluating filgrastim, carboplatin, and 6 other interventions for Brain Tumor and Central Nervous System Tumor. Completed, enrolled 378 participants across 165 sites in 6 countries.
Detailed Summary
RATIONALE: 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.
Study Details
Timeline
Interventions
Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously.
Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA \<0.45m2 the dose is 12.5 mg/kg/day.
Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA\<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA \< 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA\<0.45m2 the dose is 0.05mg/kg.
Given once daily 5 days a week for 6-6½ weeks
Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA\<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.