Coagulopathy in Newly Diagnosed Pediatric Patients with Malignancies

Objective: The objective of this study is to estimate the effect of Vitamin D3 supplementation on endogenous Vitamin D3 level and inflammatory biomarkers in newly diagnosed pediatric patients.Methods: The patients were given oral Vitamin D3, and they divided into three groups: The first group (25 healthy pediatrics), the second group (25 newly diagnosed pediatric patients) treated with daily insulin regimen only, and the third group (25 newly diagnosed pediatric patients) treated with Vitamin D3 (2000 IU/day) with daily insulin regimen; all patients were treated for 90 days; and blood samples were taken at baseline and after 45 days and 90 days of starting Vitamin D3 to assess its potential effect on the levels of Vitamin D, serum calcium, serum alkaline phosphatase levels, and other inflammatory markers.Results: The results of the current study showed that serum IL-1β significantly declined in patients receiving Vitamin D3, while serum Vitamin D3, serum calcium, and interleukins-4 were significantly increased in patients receiving Vitamin D3.Conclusion: Vitamin D3 in a daily dose of 2000 IU/day for 90 days results in favorable immune response and increase of serum Vitamin D3 for pediatric new diagnosed Type 1 diabetes mellitus patients.

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Hypertransaminasemia in Newly Diagnosed Pediatric Patients With Celiac Disease

Journal of Pediatric Gastroenterology and Nutrition ◽

10.1097/mpg.0000000000001153 ◽

2016 ◽

Vol 63 (3) ◽

pp. 340-343 ◽

Cited By ~ 8

Author(s):

Grace J. Lee ◽

Brendan Boyle ◽

Tracy Ediger ◽

Ivor Hill

Keyword(s):

Celiac Disease ◽

Pediatric Patients ◽

Newly Diagnosed

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Opioid utilization among pediatric patients treated for newly diagnosed acute myeloid leukemia

PLoS ONE ◽

10.1371/journal.pone.0192529 ◽

2018 ◽

Vol 13 (2) ◽

pp. e0192529 ◽

Cited By ~ 8

Author(s):

Kelly D. Getz ◽

Tamara P. Miller ◽

Alix E. Seif ◽

Yimei Li ◽

Yuan-Shung V. Huang ◽

...

Keyword(s):

Acute Myeloid Leukemia ◽

Myeloid Leukemia ◽

Pediatric Patients ◽

Newly Diagnosed ◽

Acute Myeloid

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RBTT-09. A PHASE 1 STUDY OF CEMIPLIMAB IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY (R/R) SOLID AND CENTRAL NERVOUS SYSTEM (CNS) TUMORS

Neuro-Oncology ◽

10.1093/neuonc/noz175.921 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi220-vi220

Author(s):

Cassie Kline ◽

Jonathan D Schoenfeld ◽

Paul J Catalano ◽

Jingjin Li ◽

Anne J Paccaly ◽

...

Keyword(s):

Dose Escalation ◽

Pediatric Patients ◽

Phase 1 ◽

Survival Rates ◽

Progression Free Survival ◽

Cns Tumors ◽

Newly Diagnosed ◽

Age Cohorts ◽

Advanced Malignancies ◽

Efficacy Assessment

Abstract DIPG and HGG lead to the majority of pediatric cancer-related deaths. Despite multimodal treatment, the 2-year survival rates for DIPG and HGG are less than 10% and 20%, respectively. Anti-PD-1 therapy combined with radiotherapy has demonstrated synergistic anti-tumor effects. Cemiplimab, a human PD-1 monoclonal antibody, has demonstrated safety and efficacy in patients with advanced malignancies. Combination of cemiplimab with radiation has the potential to be an effective treatment for pediatric patients with DIPG or HGG. This is a multicenter, Phase 1 and early efficacy study (NCT03690869). Phase 1 will enroll pediatric patients with R/R solid or CNS tumors (N≥30) into two age cohorts (0 to < 12 and 12 to < 18 years). Cemiplimab will be administered intravenously every 2 weeks as monotherapy. Primary objectives of Phase 1 are to confirm safety and assess the pharmacokinetics (PK) of cemiplimab to recommend a Phase 2 dose (RP2D) for clinical efficacy assessment. The Efficacy phase will enroll patients with newly diagnosed DIPG or HGG (dose escalation: N≥12 patients each; dose expansion: N≤40 patients each), or recurrent HGG (dose escalation: N≥6 patients; dose expansion: ≤20 patients) into two age cohorts (≥3 to < 12 years and 12 to ≤25 years). There will be two treatment arms for patients with newly diagnosed DIPG or HGG: cemiplimab in combination with conventionally fractionated (Arm 1) or hypofractionated (Arm 2) radiotherapy. Patients with recurrent HGG will receive cemiplimab concomitantly with reirradiation. All patients will continue cemiplimab as monotherapy at completion of combination therapy. Primary objectives of Efficacy Phase are to confirm safety and anticipated RP2D, assess PK, and determine survival and antitumor activity at 12 months (overall survival for newly diagnosed DIPG and recurrent HGG; progression-free survival for newly diagnosed HGG) of cemiplimab when given concomitantly with radiation. This study is currently recruiting patients across multiple sites.

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