Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

Trial ID or NCT#

NCT01032070

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: 1 Year to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
Exclusion Criteria:
  1. * 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
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Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD
Neuro-oncologist, Pediatric neurologist
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Neyssa Marina

Contact us to find out if this trial is right for you.

Contact

Peds Hem/Onc CRAs
650-723-5535

View on ClinicalTrials.gov