Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma

Inclusion Criteria

• •Patients must be enrolled before treatment begins.
• •Patients must be ≥ 12 months and \< 22 years of age at the time of diagnosis.
• •The target tumors are primary brain non-metastatic (M0) ependymomas tumors. Patients must have histologic verification of an ependymoma at diagnosis. Patients with the following world health organization (WHO) diagnoses will be eligible for this study:Ependymoma (Subtypes: cellular, papillary, clear cell and tanycytic) and Anaplastic Ependymoma
• •Life expectancy of ≥ 8 weeks.
• •Newly diagnosed ependymoma and must not have had any prior chemotherapy or radiotherapy.
• •All patients must have:
• •* A pre-operative MRI scan of the brain with and without contrast. NOTE: CT scans are NOT sufficient for study eligibility since radiation therapy planning and responses will be based on MRI scans only.
• •* Post-operative head MRI scan with and without contrast (preferably within 72 hours post-operatively).
• •* Spinal MRI (T-1 weighted imaging with and without gadolinium) is required within 28 days of surgery if done post-operatively and within 14 days of surgery if done pre-operatively. For posterior fossa tumors, pre-operative MRI scans are preferred because surgically induced inflammation/blood can be difficult to distinguish from tumor.
• •* Lumbar CSF cytology examination obtained between 7 and 31 days following surgery.
• •* Adequate bone marrow function, defined as:
• •* Peripheral absolute neutrophil count (ANC) \>1500/μL
• •* Platelet count ≥ 100,000/μL (transfusion independent)
• •* Hemoglobin ≥ 10.0 gm/dl (may receive RBC transfusions)
• •* Adequate renal function defined as:
• •* Serum creatinine \< 1.5 times the upper limit of normal based on the patient's age, or creatinine clearance greater than 60 ml/min/1.73 m² corrected for age and body surface area.
• •* Adequate liver function defined as:
• •* Total bilirubin \<1.5 x the institutional normal
• •* SGOT (AST) or SGPT (ALT) \<2.5 x institutional normals.
• •Patients must begin chemoradiotherapy within 56 days of definitive surgery.
• •All patients and/or their parents or legal guardians must sign a written informed consent
• •Patients must provide assent as per local IRB guidelines (if applicable).
• •Patients and/or their families must consent to the mandatory biology studies, including serum Survivin levels, CSF Survivin levels, paraffin-embedded tissue and fresh-frozen tissue when available.
• •Karnofsky/Lansky scoring greater than 50.
• •Corticosteroid supportive care is permissible at the clinician's discretion prior to and during chemo-radiotherapy.
• •Anti-seizure medication support is permitted as necessary and at the treating physician's discretion.
• •Exclusion:
• •Prior chemotherapy or prior radiotherapy
• •Patients who are pregnant or breast feeding, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, a condom with a contraceptive sponge or suppository or abstinence.
• •Patients who are unable to undergo MR imaging
• •Patients with evidence of metastatic disease on spine MRI or CSF sampling
• •Patients with post-operative residual tumor \> 0.5 cm, unless a repeat surgery is performed making the residual tumor less than 1.5 cm². Note: Timing for enrollment and initiation of therapy will begin after second surgery if a repeat surgery is performed.