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

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ClinicalTrials.gov Identifier: NCT01273090
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : January 30, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE January 10, 2011
Last Update Posted Date January 30, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
  • Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma [ Time Frame: 21 Days ]
  • Toxicities of imetelstat sodium [ Time Frame: Up to 30 days post-treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
  • Maximum-tolerated dose and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma
  • Toxicities of imetelstat sodium
Change History Complete list of historical versions of study NCT01273090 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma
Official Title  ICMJE A Phase 1 Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Lymphoproliferative Disorder
  • Small Intestine Cancer
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: imetelstat sodium
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Study Arms  ICMJE Experimental: Treatment
Interventions:
  • Drug: imetelstat sodium
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2014)
34
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2011)
45
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01273090
Other Study ID Numbers  ICMJE ADVL1112
COG-ADVL1112
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Patrick A. Thompson, MD Baylor College of Medicine
PRS Account Children's Oncology Group
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP