Pediatric Brain Tumor Consortium Study
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Pediatric Brain Tumor Consortium Study
The Pediatric Brain Tumor Consortium Study on CT site is now listed as completed. This study is not Geron sponsored and started in 2013. It has been under the radar. If remarkable then I would anticipate presentation at ASCO. Recall that the study was slated to enroll about 90 patients but enrollment was terminated at about half that when two patients had intracranial bleeding. Previous path studies have shown imetelstat at the "very center" of tumor. Multiple basic science studies suggest cellular anti tumor effects. We shall see. Here's hoping. bp
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Fishermangents
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Re: Pediatric Brain Tumor Consortium Study
Good post. Is there any documentation to be found about this study?
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Fishermangents
- Site Admin
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Re: Pediatric Brain Tumor Consortium Study
I found this:
A Phase 1 Trial of Imetelstat in Children with Refractory or Recurrent Solid Tumors: A Children’s Oncology Group Phase 1 Consortium Study (ADVL1112)
Published online 2013 Oct 4
Purpose
Imetelstat is a covalently-lipidated 13-mer thiophosphoramidate oligonucleotide that acts as a potent specific inhibitor of telomerase. It binds with high affinity to the template region of the RNA component of human telomerase (hTERC ) and is a competitive inhibitor of telomerase enzymatic activity. The purpose of this study was to determine the recommended phase 2 dose of imetelstat in children with recurrent or refractory solid tumors.
Experimental Design
Imetelstat was administered intravenously over two hours on days 1 and 8, every 21 days. Dose levels of 225, 285, and 360 mg/m2 were evaluated, using the rolling-six design. Imetelstat pharmacokinetic and correlative biology studies were also performed during the first cycle.
Results
Twenty subjects were enrolled (median age 14 yrs; range 3–21). Seventeen were evaluable for toxicity. The most common toxicities were neutropenia, thrombocytopenia, and lymphopenia, with dose-limiting myelosuppression in two of six patients at 360 mg/m2. Pharmacokinetics were dose dependent with a lower clearance at the highest dose level. Telomerase inhibition was observed in peripheral blood mononuclear cells at 285 and 360 mg/m2. Two confirmed partial responses osteosarcoma (n=1) and Ewing sarcoma (n=1) were observed.
Conclusions
The recommended phase 2 dose of imetelstat given on days 1 and 8 of 21-day cycle is 285 mg/m2
Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4079262/
ps: any idea how these dosings can be comapared with the IMerge dosing?
A Phase 1 Trial of Imetelstat in Children with Refractory or Recurrent Solid Tumors: A Children’s Oncology Group Phase 1 Consortium Study (ADVL1112)
Published online 2013 Oct 4
Purpose
Imetelstat is a covalently-lipidated 13-mer thiophosphoramidate oligonucleotide that acts as a potent specific inhibitor of telomerase. It binds with high affinity to the template region of the RNA component of human telomerase (hTERC ) and is a competitive inhibitor of telomerase enzymatic activity. The purpose of this study was to determine the recommended phase 2 dose of imetelstat in children with recurrent or refractory solid tumors.
Experimental Design
Imetelstat was administered intravenously over two hours on days 1 and 8, every 21 days. Dose levels of 225, 285, and 360 mg/m2 were evaluated, using the rolling-six design. Imetelstat pharmacokinetic and correlative biology studies were also performed during the first cycle.
Results
Twenty subjects were enrolled (median age 14 yrs; range 3–21). Seventeen were evaluable for toxicity. The most common toxicities were neutropenia, thrombocytopenia, and lymphopenia, with dose-limiting myelosuppression in two of six patients at 360 mg/m2. Pharmacokinetics were dose dependent with a lower clearance at the highest dose level. Telomerase inhibition was observed in peripheral blood mononuclear cells at 285 and 360 mg/m2. Two confirmed partial responses osteosarcoma (n=1) and Ewing sarcoma (n=1) were observed.
Conclusions
The recommended phase 2 dose of imetelstat given on days 1 and 8 of 21-day cycle is 285 mg/m2
Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4079262/
ps: any idea how these dosings can be comapared with the IMerge dosing?