Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Oncology, Pediatric Brain Tumor
NCT ID: NCT01096368 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-239

 

This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Susan Chi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Ebb, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: - 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 PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior treatment for ependymoma other than surgical intervention and corticosteroids
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