Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01916187|
Recruitment Status : Withdrawn (drug company withdrww support following a re-examination of the benefit-risk assessment for the investigational use of imetelstat in this population)
First Posted : August 5, 2013
Last Update Posted : February 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Imetelstat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Imetelstat Given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children With Recurrent and/or Refractory Neuroblastoma|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
285 mg/m2/dose, IV, for 2 hours. Days 1 and 8 every three weeks.
- Effectiveness of Imetelstat in pediatric dose [ Time Frame: 24 month ]Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee in patients with relapsed and/or refractory neuroblastoma, to confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid.
- Impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour cells. [ Time Frame: 24 months ]Bone marrow aspirates, biopsies and blood samples for CC assay: at baseline, end of cycles 1 and 2 then end of every other cycle will be assessed in patients with relapsed and/or refractory neuroblastoma to assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells.
- Changes in plasma C-circles [ Time Frame: 24 months ]
In patients with relapsed and/or refractory neuroblastoma to evaluate:
- The correlation of tumour and plasma C-circles.
- The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT).
- Changes in plasma C-circles induced by treatment with imetelstat.
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): NCT01916187
|Montreal, Quebec, Canada, H3T 1C5|
|Study Chair:||Victor Lewis||Alberta Children's Hospital, Southern Alberta Children's Cancer Program, AB Canada|