ADVL1112: A Phase I Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas

Why are we doing this research?

This phase I clinical trial is studying the side effects and best dose of imetelstat sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.

Who can participate?

Diagnosis of refractory or recurrent solid tumors, including lymphoma

  • No CNS tumors or known CNS metastases (Part A, dose escalation)

CNS tumors or known CNS metastases allowed (Part B, maximum-tolerated dose or recommended phase II dose)

  • No prior or concurrent CNS hemorrhage on a baseline MRI within the past 14 days
  • All patients must have histologic verification of malignancy at original diagnosis or relapse except for:
  • Intrinsic brain stem tumors
  • Optic pathway gliomas
  • Pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG
  • Measurable or evaluable disease
  • Disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood count criteria and they are not known to be refractory to red cell or platelet transfusions


Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799