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
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Childhood Solid Tumor, Protocol Specific||Drug: imetelstat sodium Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
|Experimental: Treatment||Drug: imetelstat sodium Other: laboratory biomarker analysis Other: pharmacological study|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273090
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|Principal Investigator:||Patrick A. Thompson, MD||Baylor College of Medicine|