Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The efficacy and tolerance of recombinant leukocyte A interferon (interferon alpha-2a) in 30 patients with metastasized malignant melanoma in clinical stages III and IV were tested in a phase II study. During the first 10 weeks, the patients received 18 X 10(6) IU interferon alpha-2a i.m. daily and afterwards the same dose three times a week for a further four months. In 21 patients, the tumor growth was progressive. In six patients in clinical stage IV, there was a standstill for at least two months, and in three patients in clinical stage III, there was complete remission lasting between 12 and 16 months so far. The side effects of therapy differed in the individual patients. Fever, chills, limb pain, tiredness, nausea and lack of appetite were observed most often. All these symptoms as well as the frequently occurring leukopenia and elevation of the transaminases were especially pronounced at the beginning of therapy. They were dose-dependent, but reversible.
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PMID:[Recombinant leukocyte A interferon in metastasized malignant melanoma]. 381 82

Twelve homosexual patients with Kaposi's sarcoma associated with the acquired immune deficiency syndrome (AIDS) were treated with a preparation of purified human lymphoblastoid interferon (Wellferon [Burroughs Wellcome, Research Triangle Park, NC]). They were given a dose of 20 X 10(6) U/m2 intramuscularly daily for approximately two months. Responders continued their treatment on a maintenance schedule of 20 X 10(6) U/m2 three times a week. Four patients experienced complete remissions, and four experienced partial remissions that resulted in a total response rate of 67%. The median duration of treatment was 14 weeks (7 to 28+ weeks), and the median response duration was 28+ weeks (19 to 29+ weeks). Of the four patients in complete remission, one relapsed at 25 weeks and one at 26 weeks; the other two remained in complete remission at 28 and 29+ weeks. The clinical toxicity consisted of chills, fever, fatigue, and asthenia. Hematologic toxicity was similar to that previously described for other preparations of alpha-interferon and consisted of moderate leukopenia and thrombocytopenia. Asthenia, a condition present in all 12 patients, was severe in 50%. A minimal tumor burden, the absence of circulating interferon before treatment, and a performance status of greater than or equal to 90% on the Karnofsky scale were related to an improved response rate. Measurement of immunologic parameters showed significant declines in the already impaired T cell levels, lymphocyte blastogenic response to concanavalin A, monocyte-mediated antibody-dependent cellular cytotoxicity, and monocyte-adherence. Activation of natural killer cells was not noted, and no life-threatening infections occurred during treatment. These data suggest that human lymphoblastoid interferon is an active agent in the treatment of Kaposi's sarcoma, and its use warrants further study in a larger number of patients.
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PMID:Treatment of acquired immunodeficiency syndrome--related Kaposi's sarcoma with lymphoblastoid interferon. 387 49

A phase II study of recombinant interferon alpha A (Ro 22-8181) for malignant brain tumors was jointly conducted at 21 medical institutes in order to evaluate its clinical effects and side effects. Treatment started with exclusive administration of Ro 22-8181 at 3 X 10(6) U/day, which was increased appropriately after confirmation of its safety, until an optimum dose permitting long-term administration was achieved for each patient. The dose thus determined was intramuscularly administered daily. Among those treated, 39 patients were available for evaluation. The percentage of partial responses according to the "Criteria for the Evaluation of Clinical Effects of Cancer Chemotherapy on Solid Tumor" by Koyama and Saito was 10.3% (4/39). Histologically, this was 7.1% (1/14) for glioblastoma and 14.3% (3/21) for malignant astrocytoma. Side effects included fever (57.3%), anorexia (34.1%), general fatigue (31.7%), leukopenia (52.4%) and thrombocytopenia (30.5%), and increased GOT and GPT (40.2%). In view of the success even in previously treated patients, and the side effects observed, Ro 22-8181 may be accepted as a useful addition to the treatment of malignant brain tumors.
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PMID:[Phase II study of recombinant leukocyte A interferon (Ro 22-8181) in malignant brain tumors]. 388 62

Eighteen patients with advanced metastatic gastrointestinal cancer (stomach cancer 7, liver cancer 9, pancreas cancer 2) were treated with human recombinant interferon alpha-2 at doses of 3.0 X 10(6)-10.0 X 10(6) IU/body i.m. daily or every second day, 30 X 10(6) IU/body for five consecutive days every four weeks, or 30 X 10(6) IU/body once weekly. No tumor response was demonstrated in any of our cases. Among fifteen evaluable cases, nine had stabilization of evaluable disease at four weeks, but six showed progressive disease. On the other hand, fever, chills, fatigue, anorexia, nausea and vomiting were pronounced. In two cases, CNS toxicities developed. In some instances, leukopenia, thrombocytopenia, decrease of hemoglobin content and elevation of transaminase were observed. According to these findings, single use of recombinant interferon alpha-2 at the dose schedule outlined above does not seem to be of use for the treatment of advanced gastrointestinal cancer.
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PMID:[Phase II studies of interferon alpha-2 Sch 30500 in advanced gastrointestinal carcinoma]. 389 54

Recombinant interferon alpha-2 (Sch 30500) was administered to 29 patients with advanced gynecological cancers (14 patients with cancer of the cervix, 8 with ovarian cancer, 4 with uterine sarcoma, 2 with endometrial cancer and 1 with unclassified cancer). No antitumor effects (CR and PR) were noted in 23 evaluable patients. Side effects observed were fever, tachycardia, diarrhea, chills, general fatigue, anorexia, nausea and vomiting. In some patients, leukopenia, decrease of hemoglobin and elevation of SGOT and SGPT were observed. No production of antibody for Sch 30500 was noted.
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PMID:[Clinical study of recombinant interferon alpha-2 (Sch 30500) in advanced gynecological cancers]. 389 57

Effectiveness of recombinant DNA (rDNA) human interferon alpha 2 (IFN alpha 2) in advanced breast cancer was evaluated in 14 patients who had received prior endocrine and/or cytotoxic therapy. After randomization, 7 patients received IFN alpha 2 two million IU m-2 day-1, s.c., 3 times a week (schedule 1) and 7 patients received 50 million IU m-2 day-1, i.v., for 5 consecutive days, every 3 weeks (schedule 2). Treatment duration was 4-21 weeks in schedule 1 and 6-24 weeks (2-8 courses) in schedule 2. Regressions were not achieved with either schedule. Treatment was associated with significant toxicity and was more severe in schedule 2. Dose limiting toxicities were leukopenia, elevation of liver enzymes, hyperglycemia and fatigue. Serum IFN activity was low or undetectable in patients on schedule 1 and high in patients on schedule 2. At 24 h, serum IFN activity was detectable in only 1/6 patients on schedule 1 as compared to 3/7 patients on schedule 2. IFN neutralizing factors were detected in the serum of only 1 patient prior to treatment but none were detected in any of the patients during or after discontinuation of treatment (4-24 weeks). IFN alpha 2 increased the expression of both HLA class 1 antigens and beta 2 microglobulin in peripheral blood lymphocytes in vivo. This effect was dose related.
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PMID:Recombinant DNA human interferon alpha 2 in advanced breast cancer: a phase 2 trial. 391 78

A phase I study of VP was undertaken using the methods of a single (40 cases; range of dose levels 30-540 mg/m2) and 5-day (41 cases; range of dose levels 40-140 mg/m2/day) intravenous administration. The dose-limiting toxicity of VP was moderate to severe leukopenia. MTD was estimated to be 540 mg/m2 for a single and 140 mg/m2/day for 5-day administration. The median days to WBC nadir from the start of therapy and to recovery from reaching the nadir were 10 and 10.5 for single, and 15 and 7 for 5-day administration, respectively. Thrombocytopenia was less frequent and less pronounced than leukopenia. Mild gastrointestinal disturbances and alopecia were frequently observed. Transient hepatic dysfunction, fever, headache, fatigue, dyspnea, hypotension, and pain along the vein were also encountered in a small number of patients. There were no cases with renal, neurologic or cardiac toxicity. Objective tumor regression was seen in one case each of IBL(CR), bladder cancer, non-Hodgkin's lymphoma and ATL (PR). The post-infusion plasma decay of VP in 4 cases given 80-120 mg/m2 by a single administration was biphasic with t1/2 alpha ranging from 0.13 to 0.39 h and t1/2 beta ranging from 3.33 to 4.85 h. No accumulation of VP was found in plasma after five repeated daily doses. Doses of 360-480 mg/m2 by single and 80-100 mg/m2/day by 5-day administration repeated every 3 to 4 weeks can therefore be recommended for phase II studies in good-risk patients.
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PMID:[A phase I study of VP-16-213 (VP, etoposide) by single and 5-day intravenous administration]. 394 9

Twenty patients with soft tissue sarcoma were treated with iv human fibroblast interferon (beta-interferon). Each cycle of treatment involved 5 X 10(6) units over 10 minutes, then 5 X 10(6) units iv over 3 hours daily X 10 with cycles repeated every 20 days X 3. Maintenance therapy was given twice weekly if disease was stable or responsive after three therapy periods. One patient had a partial response to treatment and six patients experienced stable disease for variable periods of time. Toxicity (fever, fatigue, leukopenia, hepatic enzyme elevations) was moderate and tolerable; therapy (except in one case of profound granulocytopenia) was neither interrupted nor discontinued because of toxicity. We conclude that beta-interferon in the dose and schedule used has limited value for soft tissue sarcoma.
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PMID:Treatment of soft tissue sarcoma with fibroblast interferon (beta-interferon): an American Cancer Society/Illinois Cancer Council Study. 394 93

Recombinant leukocyte A interferon is a highly purified single molecular species of alpha-interferon prepared by recombinant DNA methods. In 1982, a phase II trial to evaluate the efficacy of recombinant leukocyte A interferon for patients with previously treated chronic lymphocytic leukemia was begun, and 19 patients were entered in this study. Patients received one of two dose schedules depending on their pretreatment platelet counts. Those with platelet counts greater than 100,000/mm3 received 50 X 10(6) units/m2 intramuscularly three times weekly, with dose reductions to 25 X 10(6) units/m2 and 5 X 10(6) units/m2 for unacceptable toxicity. Those with platelet counts less than 100,000/mm3 received 5 X 10(6) units/m2 intramuscularly three times weekly. Toxicity was dose-dependent and included fever, chills, fatigue, anorexia, myalgias, headache, leukopenia, and thrombocytopenia. Response was evaluable in all but one of the patients entered in this study. Two of the 12 patients treated with 50 X 10(6) units/m2 had a partial response, three had no response, and seven had progressive disease. Of the six patients starting at 5 X 10(6) units/m2 in whom response was evaluable, two had no response and four had progressive disease. Five patients with progressive disease (three at 50 X 10(6) units/m2 and two at 5 X 10(6) units/m2) had an acceleration of disease while receiving recombinant leukocyte A interferon. It is concluded that the dose and schedule of recombinant leukocyte A interferon therapy tested in this study are not effective in previously treated patients with advanced chronic lymphocytic leukemia.
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PMID:Phase II trial of recombinant leukocyte A interferon in patients with advanced chronic lymphocytic leukemia. 397 47

A clinical Phase I study of recombinant human interferon alpha A (Ro 22-8181) was performed in patients with malignant tumors; twenty of them received an American product and seven others a domestic product. Both products were administered in single intramuscularly injected doses of 18, 36, 50, 75 and 100 X 10(6)U. Main side effects included fever and influenza-like symptoms (headache, chill/shivering, general fatigue, lumbago), and digestive symptoms (anorexia, nausea/vomiting). Numbness of fingers or limbs and somnolence were also observed in higher dose groups, but these symptoms all disappeared on the day of administration or by the 3rd day after administration. Abnormal laboratory findings included leukopenia, granulocytopenia, lymphocytopenia, thrombocytopenia and increased GOT/GPT/LDH, but these returned to normal by the 10th day after administration. The peak blood concentration was correlated with the dose, falling to the base line 72 hr after administration. The American product and the domestic product were nearly comparable in the type and incidence of their side effects, and also produced generally comparable blood concentrations. Furthermore, increased anti-IFN-alpha antibody titer was not observed in any of the patients; and the Prick Test proved negative in all of them. No significant changes were observed in any immunological parameters, either.
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PMID:[Phase I study of recombinant human interferon alpha A (Ro 22-8181) in patients with malignant tumors]. 400 81


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