Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma
Condition: Brain and Central Nervous System Tumors; Lymphoma; Lymphoproliferative Disorder; Small Intestine Cancer; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Intestinal Neoplasms; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: 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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To estimate the maximum-tolerated dose (MTD) and/or recommended phase II dose of
           imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma.

        -  To define and describe the toxicities of imetelstat sodium.

        -  To characterize the pharmacokinetics of imetelstat sodium in children with refractory or
           recurrent solid tumors or lymphoma.

      Secondary

        -  To determine, in a preliminary manner, the antitumor effects of imetelstat sodium in
           children with refractory or recurrent solid tumors or lymphoma. (exploratory)

        -  To provide preliminary assessment of the biological activity of imetelstat sodium in
           children with recurrent or refractory malignancies by assessing telomerase activity,
           telomere length, hTERT protein, hTERT mRNA, and hTR levels in patient peripheral blood
           mononuclear cells (PBMNC) samples pretreatment and on treatment. (Exploratory)

        -  To assess telomerase activity, hTERT expression, telomere length, hTERT protein, hTERT
           mRNA, and hTR levels in patients' pretreatment tumor samples. (Exploratory)

      OUTLINE: This is a multicenter, dose-escalation study.

      Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every
      21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

      Patients undergo blood sample collection at baseline and periodically during study for
      pharmacokinetic and correlative studies. Tumor tissue samples from diagnosis and/or
      subsequent tumor resections or biopsies may also be collected for correlative studies.

      After completion of study therapy, patients are followed up for 30 days.
    

Intervention name(s): imetelstat sodium; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention MeSH terms: Imetelstat; Motesanib diphosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific; recurrent childhood anaplastic large cell lymphoma; recurrent childhood grade III lymphomatoid granulomatosis; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; recurrent childhood brain stem glioma; recurrent childhood anaplastic astrocytoma; recurrent childhood anaplastic oligoastrocytoma; recurrent childhood anaplastic oligodendroglioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood diffuse astrocytoma; recurrent childhood fibrillary astrocytoma; recurrent childhood gemistocytic astrocytoma; recurrent childhood giant cell glioblastoma; recurrent childhood glioblastoma; recurrent childhood gliomatosis cerebri; recurrent childhood gliosarcoma; recurrent childhood oligoastrocytoma; recurrent childhood oligodendroglioma; recurrent childhood pilocytic astrocytoma; recurrent childhood pilomyxoid astrocytoma; recurrent childhood pleomorphic xanthoastrocytoma; recurrent childhood protoplasmic astrocytoma; recurrent childhood subependymal giant cell astrocytoma; recurrent childhood visual pathway and hypothalamic glioma; recurrent childhood visual pathway glioma; childhood pineal parenchymal tumor; recurrent childhood central nervous system embryonal tumor; childhood central nervous system choriocarcinoma; childhood central nervous system germ cell tumor; childhood central nervous system germinoma; childhood central nervous system mixed germ cell tumor; childhood central nervous system teratoma; childhood central nervous system yolk sac tumor; recurrent childhood pineoblastoma; childhood diffuse large cell lymphoma; childhood nasal type extranodal NK/T-cell lymphoma; childhood nodular lymphocyte predominant Hodgkin lymphoma; angioimmunoblastic T-cell lymphoma; childhood Burkitt lymphoma; childhood grade III lymphomatoid granulomatosis; childhood immunoblastic large cell lymphoma; cutaneous B-cell non-Hodgkin lymphoma; hepatosplenic T-cell lymphoma; intraocular lymphoma; noncutaneous extranodal lymphoma; peripheral T-cell lymphoma; post-transplant lymphoproliferative disorder; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; small intestine lymphoma