Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma

NCT01273090 | Completed Phase 1

• 2 other identifiers: ADVL1112COG-ADVL1112
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 23

Brief 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.

Conditions

Brain and Central Nervous System Tumors; Lymphoma; Lymphoproliferative Disorder; Small Intestine Cancer; Unspecified Childhood Solid Tumor, Protocol Specific

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

Outcome Measures

Primary Outcomes (2)

• Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma

  21 Days

• Toxicities of imetelstat sodium

  Up to 30 days post-treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: imetelstat sodium; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

imetelstat sodium DRUG

Treatment

laboratory biomarker analysis OTHER

Treatment

pharmacological study OTHER

Treatment

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% (patients \> 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years of age) * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ (transfusion-independent, defined as not receiving platelet transfusion within the past 7 days prior to enrollment) * Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age and/or gender as follows: * 0.6 mg/dL (1 to \< 2 years of age) * 0.8 mg/dL (2 to \< 6 years of age) * 1.0 mg/dL (6 to \< 10 years of age) * 1.2 mg/dL (10 to \< 13 years of age) * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age) * 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age) * Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN) * ALT ≤ 110 U/L (ULN for ALT is 45 U/L) * Serum albumin ≥ 2 g/dL * aPTT \< 1.2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use an effective contraception method * No uncontrolled infection * No patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study PRIOR CONCURRENT THERAPY: * Recovered from acute toxic effects of all prior anti-cancer chemotherapy, immunotherapy, or radiotherapy * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) * At least 14 days since prior long-acting growth factor (e.g., Neulasta) or ≥ 7 days since prior short-acting growth factor * At least 7 days since prior biologic or anti-neoplastic agent * At least 6 weeks since any type of prior immunotherapy (e.g., tumor vaccines) * At least 3 half-lives since last dose of a monoclonal antibody * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 24 weeks since prior total-body irradiation, craniospinal radiotherapy, or radiation to ≥ 50% of the pelvis * At least 6 weeks since prior substantial bone marrow radiation * At least 12 weeks since prior transplantation or stem cell infusion with no evidence of active graft vs host disease * Prior and concurrent stable or decreasing dose of corticosteroids within the past 7 days allowed * No prior allogeneic transplant * No other concurrent investigational drug * No other concurrent anticancer agents including chemotherapy, radiotherapy, immunotherapy, or biologic therapy * No concurrent cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post-bone marrow transplant or organ rejection post-transplant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (23)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60611, United States

Location

Riley's Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 2115, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0286, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Large-Cell, Anaplastic; Dendritic Cell Sarcoma, Interdigitating; Burkitt Lymphoma; Recurrence; Astrocytoma; Oligodendroglioma; Glioblastoma; Neoplasms, Neuroepithelial; Optic Nerve Glioma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Extranodal NK-T-Cell; Hodgkin Disease; Immunoblastic Lymphadenopathy; Intraocular Lymphoma; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

imetelstat

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Histiocytic Disorders, Malignant; Histiocytosis; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glioma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Lymphadenopathy; Eye Neoplasms

Study Officials

• Patrick A. Thompson, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

CA (2); US (21)