Imetelstat for Children With Refractory or Recurrent Solid Tumors and Lymphoma
|First Received Date ICMJE||March 30, 2012|
|Last Updated Date||November 20, 2012|
|Start Date ICMJE||March 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01568632 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To define antitumor effects and to assess the biological activity by assessing telomerase activity, telomere length, hTERT protein, hTERT mRNA and hTR levels; hTERT expression and protein, telomere length, hTERT mRNAS and hTR levels in tumor.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Imetelstat for Children With Refractory or Recurrent Solid Tumors and Lymphoma|
|Official Title ICMJE||A Phase 1 Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas|
- Imetelstat is a cancer treatment drug that may slow or stop tumor growth. It may also prevent tumors from spreading to other parts of the body. Researchers want to see if it can be a safe and effective treatment for children who have solid tumors or lymphoma that have not responded to other treatments.
- To see if imetelstat is a safe and effective treatment for children who have solid tumors or lymphoma that have not responded to other treatments.
- Children and adolescents between 1 and 21 years of age who have solid tumors or lymphoma that have not responded to other treatments.
- To preliminarily define antitumor effects of imetelstat and to assess the biological activity by assessing telomerase activity, telomere length, hTERT protein, hTERT mRNA and hTR levels in patient PBMNC samples pretreatment and while on treatment, and assess telomerase activity, hTERT expression and hTERT protein, telomere length, hTERT mRNA and hTR levels in patient's pretreatment tumor samples.
- Patients > 12 months and less than or equal to 21 years of age with recurrent or refractory solid tumors, including lymphomas, without CNS tumors or known CNS metastases, and with adequate hematologic, hepatic, renal and cardiac status. Must meet safety laboratory testing levels.
This study will include a required pharmacokinetic component, and one optional PK draw at 48 hours after the first dose (Day 1, Cycle 1). Patients will be asked to participate in optional blood and tissue correlative biology studies. Radiology studies will undergo central radiology review.
- Once MTD has been defined, up to 12 additional patients with relapsed/refractory solid tumors, including
CNS tumors and lymphomas, may be enrolled to acquire additional PK data at the recommended phase 2 dose, attempting to enroll at least 6 patients < 12 years of age. With a maximum number of patients of
45, this study is anticipated to be completed within 22 to 25 months. Up to 5 patients will be enrolled at NCI.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Imetelstat
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||October 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy, immunotherapy, or radiotherapy.
Organ Function Requirements
- Adequate Bone Marrow Function Defined as:
|Ages||1 Year to 21 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT01568632|
|Other Study ID Numbers ICMJE||120091, 12-C-0091|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP