A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study.

A Children's Oncology Group clinical trial aimed to determine if bortezomib (B) increased the efficacy of ifosfamide and vinorelbine (IV) in paediatric Hodgkin lymphoma (HL). This study enrolled 26 relapsed HL patients (<30 years) treated with two to four cycles of IVB. The primary endpoint was anatomic complete response (CR) after two cycles. Secondary endpoints included overall response (OR: CR + partial response) at study completion compared to historical controls [72%; 95% confidence interval (CI): 59-83%]. Although few patients achieved the primary objective, OR with IVB improved to 83% (95% CI: 61-95%; p = 0.32). Although not statistically different, results suggest IVB may be a promising combination.

Pharmacokinetics of intranasal and intratracheal pentoxifylline in rabbits.

STUDY OBJECTIVE: To evaluate the disposition of pentoxifylline and its metabolite, lisofylline, in New Zealand rabbits after two alternative routes of administration, intranasal and intratracheal. DESIGN: Pharmacokinetics study in an animal model. SETTING: University-affiliated animal care facility. SUBJECTS: Twenty New Zealand white rabbits divided into four groups of five rabbits each: group 1 did not receive study drug (control group), and groups 2, 3, and 4 evaluated intravenous, intranasal, and intratracheal routes of administration, respectively. INTERVENTION: Each rabbit in groups 2-4 received pentoxifylline as a single 20-mg/kg dose by their respective route of administration. MEASUREMENTS AND MAIN RESULTS: Blood samples were collected over a 24-hour period and were analyzed by using high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters evaluated were area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-infinity)), maximum concentration (Cmax), time to maximum concentration (Tmax), elimination rate constant (k(el)), and half-life (t1/2). Median pentoxifylline pharmacokinetic parameters after intravenous administration were AUC(0-infinity) 5420 ng x hr/ml, Cmax 16,727 ng/ml, Tmax 5 minutes, k(el) 0.036 minute(-1), and t1/2 19 minutes. Median pharmacokinetic parameters after intranasal and intratracheal administration, respectively, were AUC(0-infinity) 4224 and 6824 ng x hr/ml, Cmax 11,181 and 16,758 ng/ml, Tmax 5 and 5 minutes, k(el) 0.028 and 0.032 minute(-1), and t1/2 25 and 22 minutes. The metabolite, lisofylline, displayed a similar disposition after the three different routes of administration. CONCLUSION: The pharmacokinetic profiles after intranasal and intratracheal administration of pentoxifylline appear similar to those after intravenous administration. These data provide support for development of pentoxifylline intranasal and intratracheal dosage formulations that would be suitable for use in premature neonates.

Do Illustrations Improve Children's Comprehension of Assent Documents?

OBJECTIVE: The purpose of this study was to assess children's comprehension of a new assent booklet, (K(id)S(ent)), which uses pictures and written information. STUDY DESIGN: A randomized, crossover study evaluated the comprehension of assent documents by children, 7 to 11 years of age at a local elementary school. The two types of documents tested were the standard assent form and the K(id)S(ent) Assent Booklet. Participants were randomized as to which test document they received first by using a cluster randomization design. Participants read the document and then took a short quiz. The process was repeated for the other document on a separate day. Study participants were assigned a percentage score and a binary perfect score for each quiz. Mixed effects logistic and linear regression models with random intercepts were applied to the continuous percent quiz scores and binary perfect quiz scores, respectively. RESULTS: A total of 190 participants completed the standard quiz, and 195 students completed the booklet quiz. A statistically significant difference in perfect quiz scores (p=0.004) and percent quiz scores (p≤0.001) between booklet and standard form was noted. CONCLUSIONS: The quiz scores may indicate that the style of document is not the only factor influencing participant understanding.

Extrinsic iron staining in infant teeth from iron-fortified formula and rice cereal.

Extrinsic staining of teeth due to excessive iron intake has been reported previously in the literature. We describe a 7-month-old infant who presented with extrinsic teeth staining due to inadvertent over consumption of dietary iron. The infant was fed iron-fortified formula and rice cereal. Rice cereal, fortified with iron, was being used as part of a normal infant diet and as a thickening agent when added to the formula for treatment of gastroesophageal reflux. After several months of administration, "blackening" of the infant's teeth was noted by the mother. The stain was removed by the pediatric dentist who simply scraped the affected teeth. No further staining occurred after the amount of dietary iron was reduced.