Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00027846

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

Official Title:

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

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.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed intracranial ependymoma

* Differentiated ependymoma or anaplastic ependymoma
* No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
* No evidence of noncontiguous spread beyond primary site
* Initial surgical resection within the past 56 days

PATIENT CHARACTERISTICS:

Age:

* 1 to 21

Performance status:

* No restrictions

Life expectancy:

* At least 2 months

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Able to undergo MRI
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior or concurrent corticosteroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics
* More than 1 prior surgery allowed

Other:

* No other prior treatment for ependymoma

Disease(s) and\or Condition(s)

Brain Tumor

Central Nervous System Tumor

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: DRUG
    • Name: carboplatin
    • Description: 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.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: 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.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: DRUG
    • Name: etoposide
    • Description: 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.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: 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.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: RADIATION
    • Name: radiation therapy
    • Description: Given once daily 5 days a week for 6-6½ weeks
    • Arm Group Labels: Radiation (Group 2), Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: DRUG
    • Name: Mesna
    • Description: 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.
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
    • Type: PROCEDURE
    • Name: therapeutic conventional surgery
    • Description:
    • Arm Group Labels: Sub-Total Resection Any Histology or Location (STR) (Group 3)
Sponsor
  • Children's Oncology Group