Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0085593 (chills)
 4,268 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Five bone marrow transplant recipients with cytomegalovirus infections were treated with pure recombinant leukocyte A interferon produced by recombinant DNA technology from Escherichia coli. All five patients had documented interstitial pneumonia. The daily intramuscular dose of interferon ranged from 18 X 10(6) to 50 X 10(6) U; the mean duration of therapy was 11.0 days (range, 5 to 18 days). Two patients recovered, one improved, and two died. Clinical side effects (usually fever and chills) occurred in three patients. A 60% or greater reduction in the pretherapy peripheral granulocyte counts occurred in four patients, and four patients had a 37 to 80% reduction in their pretherapy platelet counts. Hematological toxicity was reversible, and there was no loss of marrow graft function. The toxicity of pure recombinant leukocyte A interferon in marrow transplants is similar to that of partially pure leukocyte interferon derived from human cells. Further controlled studies to establish the efficacy of recombinant leukocyte A interferon in marrow transplants are warranted but may be limited by hematological toxicity.
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PMID:Safety and tolerance of recombinant leukocyte A interferon in bone marrow transplant recipients. 631 Oct 88

Nineteen patients with advanced refractory metastatic breast cancer no longer responsive to chemotherapy were treated in the first phase II efficacy trial of recombinant leukocyte A interferon (IFL-rA), a highly purified single molecular species of alpha interferon prepared by recombinant DNA methods. Patients received a previously determined maximum tolerated dose for this agent (50 X 10(6) U/m2 body surface area) by intramuscular injection three times weekly for up to 3 months. The symptoms of toxicity observed in this trial resemble those previously reported for alpha interferons and include fever, chills, fatigue, anorexia, and leukopenia. All patients required dose reductions, most often for reasons of severe fatigue. Of the 17 patients evaluable for tumor response, one patient had stable disease and 16 had evidence of tumor progression. We conclude that IFL-rA is not an active agent in the treatment of advanced, refractory breast cancer when used at a maximum tolerated dose on this treatment schedule.
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PMID:Recombinant leukocyte A interferon in advanced breast cancer. Results of a phase II efficacy trial. 634 90

Thirty-three patients with renal cancer began treatment with human lymphoblastoid interferon (Wellferon) between August 1982 and February 1983. Interferon was administered as an i.m. injection at a dose of 5 X 10(6) units/sq m 3 times per week. Treatments were continued for at least 24 weeks in the absence of rapid disease progression or intolerable toxicity. Five patients demonstrated partial responses, which continued in two patients with durations of 239+ and 300+ days. Prolonged therapy was often required with a mean time to response of 99 days (22 to 190 days). Toxicity was substantial. Fever, chills, arthralgias, and myalgias occurred following most doses, but usually were well tolerated. Leukopenia and hepatic enzyme elevations were usually modest and always reversible. Dose-limiting side effects were progressive fatigue and anorexia which reversed within approximately 4 to 6 weeks after cessation of interferon therapy. There was no correlation between interferon levels, clinical toxicities, and response in this group of patients. We conclude that interferon has definite antitumor activity in renal cancer when given by this dose and schedule.
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PMID:Interferon-alpha therapy of renal cancer. 637 79

This study was designed to evaluate the clinical tolerance to multiple IM injections of rDNA-produced human alpha-2 interferon (IFN) (Schering-Plough 30500) in patients with solid tumours. IFN was administered in escalating IM doses in separate groups of patients daily for 14 days and then twice weekly for a further 10 weeks. The dosage levels were 1, 3, 10, and 30 million U/injection. Subjective toxicity could be divided into two types, acute and chronic. The acute reactions took the form of an influenza-like syndrome consisting in chills, rigors, headache, tremor, nausea, vomiting, and myalgia. These symptoms were dose-related but tachyphylaxis developed with continued dosing. The chronic toxicity consisted of malaise, lethargy, fatigue, anorexia, and confusion. These symptoms were not so dose-dependent and tended to become more severe with prolonged treatment. Objective toxicity consisted of myelosuppression and liver dysfunction. Granulocyte counts below 1.0 X 10(9)/l were seen in three patients at the 30-million-U level, with platelet counts less than 100 X 10(9)/l in two of these. Elevation of the liver enzymes were seen in all five patients treated at 30 million U, but returned to normal after 1 week without IFN in all but one patient. A tolerable dose (IM) for phase II/III studies lies between 3 and 10 million U for daily scheduling and between 10 and 30 million U for twice-weekly injections.
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PMID:A phase I toxicity study of human rDNA interferon in patients with solid tumours. 646 93

From June 1979 to June 1982 72 children with metastatic neuroblastoma older than 1 year of age at diagnosis were treated according to the protocol NB 79 of the German Society for Paediatric Oncology. The chemotherapy included three cycles of adriamycine, cyclophosphamide, vincristine, dacarbazine and five cycles of adriamycine and cyclophosphamide. 34 patients were randomized for additional beta-Interferon (Fiblaferon) treatment (10(5) U/kg daily for 3 weeks followed by 3 times a week for 21 weeks). 38 patients were not treated with Fiblaferon. The response rate was 96% including 35% complete and 61% partial remissions. Preoperative chemotherapy improved remarkably the resectability of the primary tumor without enhancing complication rates. The cumulative proportion surviving was 21% for the interferon group and 6% for the patients not treated with interferon. The cumulative recurrence free survival rate, however, was 5% for both groups. The median survival time was 19 months and the median recurrence free survival time 10 months. A serious side effect of chemotherapy was bone marrow depression (73%) resulting in 1 week delay of drug administration per cycle. The median of administered drug dosages was 87-100% of the recommended dosages. Side effects of beta-Interferon commonly decreased with time and were fever reactions (55%), shaking chills (29%), cardiovascular reactions (16%).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Intensive combined drug therapy and beta-interferon in the treatment of children with metastasizing neuroblastoma: GPO-NB 79/82 study]. 647 73

Twenty-one patients with advanced measurable colorectal carcinoma were treated with interferon (rIFN-alpha A) intramuscularly at 50 X 10(6) units/m2 thrice weekly. No patient had received chemotherapy for metastatic or recurrent disease. The average age of the patients was 60 years, and the mean initial performance status was 85 (Karnofsky scale). Nineteen patients were evaluable for response. One patient showed complete resolution of pulmonary nodules and stable liver metastases after 3 months of therapy. The other 18 patients developed progressive disease after 1-3 months of treatment. Toxicity was substantial but manageable; fevers, chills, fatigue, elevated serum glutamic-oxaloacetic transaminase, anemia, and mild leukopenia were common. rIFN-alpha A is minimally active against metastatic colorectal carcinoma.
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PMID:Minimal activity of recombinant clone a interferon in metastatic colon cancer. 648 1

Fifteen patients with advanced hematopoietic and other malignancies were treated with recombinant DNA produced Alpha 2 Interferon (IFN) (Schering) by intravenous (IV) and intramuscular (IM) routes at weekly intervals in escalating doses from 1 X 10(6) IU to 100 X 10(6) IU in order to determine the tolerance and pharmacokinetics. The most common side effects included fever, chills, myalgia, and arthralgia. At doses of 60 X 10(6) or above, severe but reversible hypotension was observed in five patients receiving interferon by intravenous route. Patients receiving interferon by intramuscular route had fever, chills, and myalgias but did not develop hypotension at the same dosage. Two patients with non-Hodgkin lymphoma showed objective evidence of regression. Our data suggest a biphasic pattern of elimination with terminal half-life ranging from 1.9 to 2.9 hours and peak titer of 16,000 units and under for IV interferon, and terminal half-life of 6 hours with peak titers of 600 units for intramuscular interferon. However, interpatient variability precludes a definite conclusion. Although the areas under the serum concentration vs time curves were similar, the intravenous route provided higher but unsustained levels of interferon than the intramuscular route.
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PMID:Pharmacokinetics and tolerance of intravenous and intramuscular recombinant alpha 2 interferon in patients with malignancies. 659 39

Human fibroblast interferon (IFN-beta) was given 13 cases of advanced gynecological cancers. Eight patients, who were clinically evaluable, were reported as follows; Patients consisted of ovarian adenocarcinoma (5), cervical adenocarcinoma (1), endometrial carcinoma (1) and tubal carcinoma (1). Route of administration was intravenous in 5 cases and intratumorous in 3 cases. IFN-beta dose ranged from 2, 650 X 10(4) to 10, 620 X 10(4) units. Clinical effects according to Koyama - Saitoh 's category was progressive disease (PD) in 7 cases and minor response (MR) only in one case who received intratumorous injection for recurrent tumor mass of tubal carcinoma in vaginal stump. Side effects of IFN-beta were chill and fever, fatigue and anorexia, leucocyte--and thrombocyte-- penia and hepatic dysfunction, though they were mild in grade and not dose-limiting factors. No anti-IFN-beta-antibodies were detected in any cases.
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PMID:[Clinical effects of human fibroblast interferon in advanced gynecological cancers]. 673 54

Eighty-one patients with a variety of refractory disseminated malignant neoplasms have been treated in the first multiple fixed-dose phase I trial of recombinant leukocyte A interferon (IFL-rA). Each patient received IFL-rA by intramuscular injection, three times weekly for 28 days. Dosages were escalated in different patients from 1 to 136 x 10(6) units per injection. The toxic reactions seen with IFL-rA resembled those of nonrecombinant leukocyte interferon and included fever, chills, fatigue, anorexia, myalgia, headache, occasional nausea and vomiting, and dose-dependent reversible leukopenia and hepatic transaminase elevations. The pharmacokinetics of IFL-rA were also comparable with nonrecombinant leukocyte interferon. Objective evidence of antitumor activity was seen in non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, breast cancer, and melanoma, indicating that IFL-rA, the first genetically engineered biological response modifier available for testing in cancer patients, is biologically active in vivo.
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PMID:A multiple-dose phase I trial of recombinant leukocyte A interferon in cancer patients. 675 47

Human fibroblast interferon(HFIF) was used in 26 patients with various malignant diseases, most of whom had previous chemotherapy. The dosages used were 3 X 10(6) IU or 6 X 10(6) IU of HFIF i. v. daily. Out of 24 evaluable patients, there were 2 partial remissions (CLL 1 and multiple myeloma 1), and 7 stable diseases (multiple myeloma 2, stomach cancer 2, non-Hodgkin's lymphoma 1, CLL 1 and malignant melanoma 1). The majority of the patients experienced fever exceeding 38 degrees C and chills, which became uncommon within several days of treatment. Other side effects included myelosuppression, general malaise, anorexia, hepatic dysfunction and renal dysfunction, which were mild and tolerable.
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PMID:[Clinical effects of human fibroblast interferon on malignant tumors]. 718 62


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