Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Condition: Recurrent or Refractory Pediatric Ependymoma
MeSH terms: Ependymoma; Recurrence
Intervention: erlotinib; etoposide
Intervention description: oral; oral
Intervention MeSH terms: Etoposide; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: pediatric; etoposide; erlotinib; phase 2; ependymoma

Summary:

      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.
    

Eligibility criteria:

        Inclusion 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

        Exclusion Criteria:

          -  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