Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Trial ID or NCT#
Status
Purpose
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.
Official Title
A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Eligibility Criteria
- - 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/µL - Platelet count > 100,000/µL - 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
- - Previously received epidermal growth factor receptor (EGFR)-targeted therapy - Previously received oral etoposide - Received craniospinal radiotherapy within 24 weeks prior to randomization - Received field radiotherapy to the target lesion within 12 weeks prior to randomization - Received symptomatic metastatic disease within 14 days prior to randomization - Received myelosuppressive chemotherapy within 21 days before randomization - Received growth factors within 7 days prior to randomization - Participating in another investigational drug trial - Received a biologic agent within 7 days prior to randomization - Received a monoclonal antibody within 28 days prior to randomization - Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization - Taking proton pump inhibitors within 14 days prior to randomization - Smoking during treatment - Pregnant or breast-feeding females
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Peds Hem/Onc CRAs
650-723-5535
View on ClinicalTrials.gov