Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates.

Background: A manufacturing process using a modified adjuvant was developed to optimize the consistency and immunogenicity for recombinant hepatitis B vaccine (control: RECOMBIVAX-HB™). This modified process hepatitis B vaccine (mpHBV), which was previously shown to have an acceptable safety and immunogenicity profile in young adults, has now been studied in newborn infants.

Methods: Healthy 1-10-day-old neonates (N=566) received 3 intramuscular doses (5μg hepatitis B surface antigen [HBsAg] per dose) of either mpHBV or control at Day 1, and Months 1 and 6.

Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma.

A Phase I trial (NCT00109109) of oral vorinostat 200, 250 or 300 mg twice daily for 5 days/week/4-week cycle or 200, 300, or 400 mg twice daily for 14 days/3-week cycle until progressive disease or intolerable toxicity was conducted. Patients with measurable, relapsed/refractory multiple myeloma were eligible. The objectives were to determine maximum tolerated doses (MTDs) and assess activity and safety.

CyberKnife frameless single-fraction stereotactic radiosurgery for benign tumors of the spine.

Object: The role of stereotactic radiosurgery in the treatment of benign intracranial lesions is well established. Its role in the treatment of benign spinal lesions is more limited. Benign spinal lesions should be amenable to radiosurgical treatment similar to their intracranial counterparts.

CyberKnife frameless single-fraction stereotactic radiosurgery for tumors of the sacrum.

Object: The role of stereotactic radiosurgery for the treatment of intracranial lesions is well established. The experience with radiosurgery for the treatment of spinal and sacral lesions is more limited. Sacral lesions should be amenable to radiosurgical treatment similar to that used for their intracranial counterparts.

CyberKnife frameless stereotactic radiosurgery for spinal lesions: clinical experience in 125 cases.

Objective: The role of stereotactic radiosurgery for the treatment of intracranial lesions is well established. Its use for the treatment of spinal lesions has been limited by the availability of effective target-immobilizing devices. Conventional external beam radiotherapy lacks the precision to allow delivery of large doses of radiation near radiosensitive structures such as the spinal cord.

Evaluation of CyberKnife frameless real-time image-guided stereotactic radiosurgery for spinal lesions.

Background: This study evaluated the CyberKnife frameless image-guided radiosurgery system for the treatment of spinal lesions.

Methods: This system utilizes the coupling of an orthogonal pair of X-ray cameras to a dynamically manipulated robot-mounted linear accelerator that guides the therapy beam to the intended target without the use of frame-based fixation. Cervical spine lesions are located and tracked relative to skull bony landmarks; lower spinal lesions are tracked relative to fiducial markers.