A phase II study of amifostine in children with myelodysplastic syndrome: a report from the Children's Oncology Group study (AAML0121).

Based on its potential role in adult myelodysplastic syndrome (MDS), the Children's Oncology Group (COG) embarked on a phase II study using amifostine in pediatric MDS (WHO 2001 criteria) patients. Responses were evaluated after two cycles. Ten patients were enrolled; five were deemed ineligible, and four withdrew after the first course. Only one patient completed two courses, and was found to be in complete remission. The study was closed after being open for 2 years due to slow accrual. Studying a rare disease like MDS may pose insurmountable obstacles even in a large clinical trials group such as COG, in part because of the changing definitions of MDS and the rarity of adult type MDS in children. The role of amifostine in pediatric MDS was not known at the time of study.

Risk determinants for catheter-associated blood stream infections in children and young adults with cancer.

BACKGROUND: Catheter-associated blood stream infections (CABSI) are frequent complications encountered with cancer treatment. In order to understand which factors might predispose to CABSIs in children and young adults, we evaluated risk for infection in association with tumor type, catheter type, and setting of occurrence. METHODS: All pediatric oncology patients having a central venous catheter (CVC) with a tunneled external (TE) or totally implantable design (TID) were prospectively followed for the occurrence of a CABSI for 12 months. CABSIs were defined in accordance with the guidelines published by the Centers for Disease Control, and were quantified as the number of occurrences per 1,000 device days. Rates of CABSIs were stratified by tumor histology, type of catheter design, and setting of occurrence. Statistical comparisons were made using the Mantel-Haenzel statistic and the Cox proportional hazard model. RESULTS: A total of 58 CABSIs were identified in 139 patients over a period of 35,935 CVC days. The overall CABSI rate was 1.6 infections per 1,000 CVC days (95% CI 1.2, 2.1). Stratified analysis demonstrated increased risk for CABSIs in hospitalized patients having TEs, and while patients with solid tumors were also at higher risk; this association was not supported by the Cox proportional hazard model. CONCLUSION: While our baseline CABSI rate was comparatively lower than for other institutions, subset analyses identified that hospitalized cancer patients having TEs are at the highest risk for developing CABSIs. Our findings may help to guide improved methods of anticipating and controlling infections in immunocompromised patients.

Dynamic re-immunization of off-treatment childhood cancer survivors: An implementation feasibility study.

There are no universally approved re-vaccination guidelines for non-transplant pediatric cancer survivors. We hypothesized that by utilizing a response-based re-vaccination schedule, we could tailor vaccine schedules in off-treatment cancer survivors. Pre-vaccination antibody levels were obtained in 7 patients at an average of 20 days after the end of treatment date. In those without protective antibody levels, we administered vaccines 3 months after completion of treatment. Revaccinating patients 3 months after the end of treatment date resulted in protective antibody levels for most vaccines. We showed, on a preliminary basis, that vaccinating non-transplanted pediatric cancer survivors can be dynamically implemented in children with recovering immune function.