A phase II investigation of pentostatin in metastatic malignant melanoma.
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Humans↗
Biomedical subjects
E Kraut
Publications and source records attributed to E Kraut.
A comprehensive phase I and II clinical investigation of fludarabine phosphate.
This article presents data from the phase I and II clinical investigations of Fludara I.V. (fludarabine phosphate) (NSC 312887), which is the 5'-phosphorylated derivative of the novel antimetabolite, 9-beta-D-arabinofuranosyl-2-fluoroadenine. The comprehensive phase I evaluation of this new antitumor agent was conducted in 51 patients with advanced malignancy and 15 additional patients with aggressive forms of leukemia. Three separate phase I schedules of drug administration were examined. Myelosuppression was the dose-limiting toxicity on each schedule administered to patients with solid tumors. The drug was also examined at higher doses in patients with leukemia, and the dose-limiting toxicity on the high-dose protocol was unacceptable: serious neurologic toxicity. The observation of antitumor responses in patients with advanced non-Hodgkin's lymphoma prompted additional phase II investigation in patients with lymphoproliferative malignancy. The encouraging phase II data demonstrate that Fludara I.V. has promise for patients with low-grade histologic subtypes of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. While interesting additional basic and clinical research projects regarding Fludara I.V. remain, it is important to expeditiously pursue approval for this drug. Adequate data exists to demonstrate that the low-dose administration of Fludara I.V. is both safe and effective. While the development of this drug has stimulated renewed interest in the clinical investigation of the chronic lymphoproliferative malignancies, the time for making it readily available to these patients has arrived.
Adult↗
Pulmonary embolism as a result of Hickman catheter-related thrombosis.
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Adult↗
A spontaneous factor V inhibitor with unexpected laboratory features.
In a patient with a spontaneous inhibitor detected against factor V, the initial pattern of laboratory results suggested a possible nonspecific (lupuslike) inhibitor, a finding that did not agree with the clinical history. Further evaluation led to the identification of the specific inhibitor. The patient was then treated successfully with platelets and immunosuppression. This case highlights the nonspecific nature of many of the procedures utilized to evaluate patients with circulating anticoagulants and underscores the need for a careful integration of clinical and laboratory data to diagnose and manage these patients properly.
Aged↗
Phase I trial of homoharringtonine administered by prolonged continuous infusion.
Cephalotaxine alkaloids have been extensively used in the Peoples Republic of China for treatment of acute leukemias and solid tumors (Yu-hua, L., Shu-fen, G., Fu-ying, Z., Shu-zhi, X., and Hui-lin, Z. Chin. Med. J., 96: 303-305, 1983). Several Phase I trials of homoharringtonine have been completed in the United States using either bolus administration or continuous infusion over a 5-day period. The major toxicities have been hypotension following rapid administration and myelosuppression when lower doses are infused over 5 to 7 days. None of these studies, however, reproduce the schedule used in China which is i.v. infusion of approximately 1 mg/day over 4-8 h for a period of 14-28 days or more, followed by a rest period of approximately 7-14 days. This study more closely reproduces that schedule as a Phase I trial by decreasing the daily dose of homoharringtonine and using a continuous infusion schedule to allow escalation of total days of treatment. Forty-eight patients entered the study. The final recommended dose of homoharringtonine is 1 mg/m2/day for 30 days followed by a 2-week rest period. The dose limiting toxicity of myelosuppression was severe and prolonged in some patients. Nonhematological toxicities were minimal and generally well tolerated. Patients should be followed with at least weekly blood counts and treatment interrupted pending full marrow recovery if the granulocyte count falls below 1,000/mm3 or the platelet count falls below 100,000/mm3.
Adult↗
Psoriatic sera decrease responses of stimulated granulocytes from normal and psoriatic subjects.
Previous studies have demonstrated alterations in polymorphonuclear leukocyte (PMNL) function in patients with psoriasis, but results have been variable. In this study we attempted to determine whether functional changes in PMNL from psoriatics represented an intrinsic cellular defect or a response to factors in serum. We evaluated the effect of the continuous presence of autologous and heterologous serum on lysozyme release and superoxide anion (O2-) generation by psoriatic and normal PMNL exposed to a soluble or particulate phagocytic stimulus. There were no differences in O2- generation or lysozyme release between normal and psoriatic PMNL without serum. However, in the presence of 10% autologous serum, these responses were significantly decreased for psoriatic PMNL (p less than .001). The results were not time-dependent and did not correlate with the extent of psoriatic involvement. The data support the hypothesis that serum factors exist in patients with psoriasis that may affect PMNL functions. The presence or absence of such factors could explain, in part, the differences between the various investigations of PMNL function in psoriasis.
Cytochrome c Group↗
Treatment of anemia in myeloproliferative disorders: a randomized study of fluoxymesterone v transfusions only.
Previously untreated patients who had anemia (hemoglobin level, less than or equal to 10 g/dL) caused by myelofibrosis (MF) (16 patients) or other myeloproliferative disorders (13 patients) were given the opportunity to participate in a prospective randomized study-to be treated either with 30 mg/day of oral fluoxymesterone and necessary transfusions or by transfusions alone. Of the 24 patients whose data could be evaluated, four (29%) of 14 responded well to fluoxymesterone therapy (hemoglobin level rise, of greater than 2 to greater than 10 g/dL and relief of symptoms of anemia), whereas, in the transfusion arm, there were no good "responders"; one of ten patients was a partial "remitter" (responder), with a rise in the hemoglobin level of 1 to 2 g/dL. All responders to fluoxymesterone therapy showed a 50% or more maximum uptake of injected ferrous citrate Fe 59 into RBC hemoglobin, whereas no nonresponder met this criterion. All responders had MF (marrow more than one third replaced by collagen). There was no significant difference in survival of patients in the two arms of the study.
Aged↗
[New aspects of pathogenesis and treatment of dysmenorrhoea (author's transl)].
Menstrual blood of 5 dysmenorrhoeic women was collected in tampons during two menstrual cycles without and four cycles with intrauterine progesterone treatment (Progestasert). Three eumenorrhoeic women served as controls. Progesterone was assayed radioimmunologically after purification and extraction. Total progesterone excretion in the menstrual blood was the same in eumenorrhoeic and dysmenorrhoeic women without treatment. An increase of menstrual progesterone excretion by the factor 13 was found during the first bleeding after insertion of progesterone T. After 12 months of treatment with Progestasert only 41.7% (2 alpha less than or equal to 0.001) of the initial progesterone amount per menstruation was found. The progesterone concentration per ml menstrual blood had decreased in the same way but was still clearly higher than eumenorrhoeic values. The results indicate that progesterone controls intrauterine prostaglandin F2alpha formation indirectly.
Dysmenorrhea↗
[The effect of progesterone uterine therapeutic system on dysmenorrhoea: prostaglandin F2alpha levels in menstrual blood (author's transl)].
The menstrual flow of five dysmenorrhoeic women was collected, four cycles with and two cycles without local intrauterine administration of progesterone (Progestasert). The menstrual flow of three eumenorrhoeic women served as control. Menstrual blood was collected by tampons stored in butyl-alcohol saturated with water. Prostaglandin F2alpha (PGF2alpha) was measured after purification and extraction by radioimmunoassay. The PGF2alpha production rate and concentration per ml of menstrual blood from dysmenorrhoeic women differed significantly from those of eumenorrhoeic women. In the treated cycles the PGF2alpha levels were significantly decreased (2 alpha less than or equal to 0,01), corresponding to eumenorrhoeic levels. These values were in accordance with the clinical results and indicate that uterine PG-synthesis is under progesterone control.
Administration, Topical↗