A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Erlotinib
- drug : Etoposide
Phase: Phase 2
Ages Eligible For Study:
- Recurrent of refractory ependymoma or subependymoma - Performance Status (PS): Lansky ? 50% for patients ? 10 years of age or Karnofsky ? 50% for patients >10 years of age - Measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks - Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy - ? 1 year to ? 21 years - Serum creatinine for patients ? 5 years in age is ? 0.8 mg/dL or Creatinine Clearance/Glomerular Filtration Rate (GFR) ? 70 mL/min/m^2 - Serum creatinine for patients > 5 and ? 10 years in age is ? 1.0 mg/dL or Creatinine Clearance/GFR ? 70 mL/min/m^2 - Serum creatinine for patients > 10 and ? 15 years in age is ? 1.2 mg/dL or Creatinine Clearance/GFR ? 70 mL/min/m^2 - Serum creatinine for patients > 15 years in age is ? 1.5 mg/dL or Creatinine Clearance/GFR ? 70 mL/min/m^2 - Total bilirubin is ? 1.5 x upper limit of normal for age - Alanine aminotransferase (ALT) ? 3 x upper limit of normal - Absolute neutrophil count > 1000/ÁL - Platelet count > 100,000/ÁL - Hemoglobin > 8 gm/dL - Neurologically stable for at least 7 days prior to randomization - If receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization - Patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug