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Oligodeoxynucleotides containing immunostimulatory CpG motifs (CpG ODN) act as potent Th1-like immune enhancers with many antigens in animal models. We have extended these observations to the first clinical evaluation of the safety, tolerability and immunogenicity of CPG 7909 when added to a commercial HBV vaccine. In a randomized, double-blind phase I dose(More)
Immunogenicity has always been an important consideration in the evaluation of pharmaceutical protein biologics. In this article, method validation parameters relevant to enzyme immunoassays are described for assays applied to the analysis of anti-drug antibodies, with special considerations for immunogenicity to therapeutic monoclonal antibodies. Common(More)
A clinical trial involving 462 colon, rectum, and breast cancer patients randomized among four different dosage regimens of 5-FU (an intravenous loading course, a weekly intravenous schedule, a nontoxic schedule, and an oral schedule) has shown a significantly better response among colon-rectum cancer patients for the intravenous loading course. In(More)
Two children with Wilms' tumor and prior thoracic radiation developed congestive heart failure at cumulative adriamycin doses of 350 mg/m2 and 400 mg/m2. Details of these two cases and a summary of previously reported adriamycin cardiotoxicity in children are presented. Dose recommendations and predictive tests are discussed.
ICRF-187 is the D-enantiomer of the racemic antitumor agent ICRF-159 and was selected for clinical trials on the basis of aqueous solubility suitable for iv administration. Eighteen patients with refractory advanced solid tumors received ICRF-187 by a 48-hour continuous iv infusion in 5% Dextrose in Water, USP. The total dose ranged from 200 to 1000(More)
Patients with objectively measurable soft tissue sarcoma, bone sarcoma, or mesothelioma who had failed at least one prior chemotherapy regimen received either bleomycin (20 U/M22 i.v. day 1 each week), chlorozotocin (150 mg/M2 i.v. q6 weeks), MGBG (500 mg/M2 i.v. each week, escalated in 50 mg/M2 weekly increments to a maximum dose of 700 mg/M2), or(More)
The appearance of acute non-lymphocytic leukemia (ANLL) in patients with other hematologic and non-hematologic malignancies is now a well recognized syndrome. These patients have an unusual form of leukemia with distinct clinical and morphological features. With improved therapy many cancer patients have experienced prolonged survival and cure. Some of(More)