Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial.

BACKGROUND: Renal cell cancer and malignant melanoma are two types of cancer that are responsive to immunotherapy. In this phase I dose-escalation study, the feasibility of large-scale expansion and safety of administering ex vivo-expanded NK-92 cells as allogeneic cellular immunotherapy in patients with refractory renal cell cancer and melanoma were determined. METHODS: Twelve patients (aged 31-74 years) were enrolled, three per cohort at cell dose levels of 1x10(8)/m(2), 3x10(8)/m(2), 1x10(9)/m(2) and 3x10(9)/m(2). One treatment course consisted of three infusions. Eleven patients had refractory metastatic renal cell cancer; one patient had refractory metastatic melanoma. RESULTS: The NK-92 cells were expanded in X-Vivo 10 serum-free media supplemented with 500 U/mL Proleukin recombinant human interleukin-2 (rhIL-2), amino acids and 2.5% human AB plasma. Final yields of approximately 1x10(9) cells/culture bag (218-250xexpansion) over 15-17 days were achievable with >or=80% viability. Infusional toxicities of NK-92 were generally mild, with only one grade 3 fever and one grade 4 hypoglycemic episode. All toxicities were transient, resolved and did not require discontinuation of treatment. One patient was alive with disease at 4 years post-NK-92 infusion. The one metastatic melanoma patient had a minor response during the study period. One other patient exhibited a mixed response. DISCUSSION: This study establishes the feasibility of large-scale expansion and safety of administering NK-92 cells as allogeneic cellular immunotherapy in advanced cancer patients and serves as a platform for future study of this novel natural killer (NK)-cell based therapy.

Applying antitrust law to nonprofit healthcare entities: arguments for a greater attention to detail.

This Article begins with an antitrust primer, then analyzes the appropriate application of antitrust principles to nonprofit healthcare providers. In light of the inherent charitable character of nonprofit healthcare providers, the author contends that the government and the courts should accord some deference to nonprofit hospitals when they are seeking approval of mergers. To date, this has not generally been the case, although a few recent court decisions have rested their approval of mergers, in part, upon the nonprofit character of the merging entities. The author, in particular, believes the paradigmatic local nonprofit hospital with a community board is less likely than a for-profit hospital to abuse any market power that it may obtain through a merger; consequently, any such merger should not be analyzed solely under the traditional presumptions of antitrust jurisprudence. Rather, the premerger analysis should involve meaningful consideration of the hospital's charitable character.

Clinical evaluation of the Bio-Pen for axial length measurement.

The axial length of 207 eyes was evaluated in a clinical comparison between the Bio-Pen biometric ruler and the Kretz 7200 MA A-scan unit. The overall correlation was 0.99. The Bio-Pen measurement averaged 0.056 mm shorter than the Kretz. The difference was statistically significant (P less than .0001). The Bio-Pen was found to be a convenient and clinically accurate biometer.

Myeloma cells in the urine.

We report two unusual manifestations of multiple myeloma in a 71-year-old man. Late in the course of his disease, myeloma cells were observed in the patient's urinary sediment. At post mortem, the source of the cells was found to be a plasmacytoma of the urinary bladder. To our knowledge, this appears to be the first report of a clearly demonstrable anatomic source for myeloma cells in the urine.

Teaching self-protection to young children.

Self-protective behaviors were taught to three preschool children in order to prevent the opportunity for abduction. An analogue measure of self-protection was developed in which confederate adults approached and verbally attempted to lure each child from the setting, before, during, and after training. A multiple baseline design across subjects was used. During baseline, all the children displayed susceptibility to the lures. Training procedures included modeling, behavior rehearsal, and social reinforcement. Within 1 week after training began, all children displayed appropriate responses to all of the lures both in the training setting and in the community.