Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma

This is an interventional treatment trial for Ependymoma focused on measuring Childhood ependymoma, Ependymoma, Survivin Read More

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.