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Biomedical subjects

W M Gallmeier

Publications and source records attributed to W M Gallmeier.

At least 19 recordsLinked to original sources
PubMed1992

Low-dose oral natural human interferon-alpha in 29 patients with HIV-1 infection: a double-blind, randomized, placebo-controlled trial.

OBJECTIVE: To evaluate clinical efficacy and toxicity of low-dose oral natural human interferon-alpha (nHuIFN alpha) on CD4+ lymphocyte counts and clinical symptoms in patients with HIV-1 infection. DESIGN: Double-blind, randomized, placebo-controlled trial with crossover. SETTING: Private practice specializing in the treatment of patients with AIDS. PATIENTS, PARTICIPANTS: Only patients with HIV-1 infection and CD4+ lymphocyte counts between 200 and 500 x 10(6)/l were included for study. Thirty out of thirty-one patients at study entry completed treatment with placebo, and 29 completed nHuIFN alpha treatment. Mean patient age was 36 years (range, 25-58 years). The 30 patients included 26 men, of whom 22 were homosexual, and four women; five were drug users and none were currently on zidovudine therapy, although three had been previously. INTERVENTIONS: Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks. MAIN OUTCOME MEASURES: Every 2 weeks, a detailed history, physical examination, and laboratory tests, including CD4+ and CD8+ lymphocyte counts, were conducted. RESULTS: There was only a slight, transient increase in mean CD4+ lymphocyte counts after 4 weeks of treatment with nHuIFN alpha, compared with a slight decline when placebo was administered. This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks. There were no significant changes in weight and clinical symptoms. All patients remained HIV-1-antibody-positive. Treatment-related adverse reactions were not observed. CONCLUSIONS: Our double-blind, randomized, placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha. Although non-toxic, our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials.

Administration, Oral↗
PubMed1992

Prevention of chemotherapy-induced nausea and emesis in patients responding poorly to previous antiemetic therapy. Comparing tropisetron with optimised standard antiemetic therapy.

In a multicentre trial, 78 patients with a variety of malignancies, who had experienced insufficient control of emesis (greater than or equal to 3 episodes within 24 hours) while receiving standard antiemetics during previous chemotherapy, were randomly assigned to receive tropisetron 5mg once daily for 5 days or conventional antiemetic drugs. No attempt was made to standardise the conventional antiemetic treatment, which was given according to the usual practice of the participating institutions. Emesis was evaluated by counting emetic episodes and nausea by asking the patients to record on a diary chart the duration and severity of the nausea. Emesis was much better controlled with tropisetron than with standard drugs, complete control during the first 24 hours being achieved in 42% and 8% of patients, respectively, (p less than 0.001). Nausea was of significantly shorter duration (6.9 vs 10.3 hours; p less than 0.01) and was less severe (p less than 0.005) in the tropisetron group. The patients' overall assessment of treatment outcome was markedly better for tropisetron than for the standard antiemetic therapy. The superior efficacy of tropisetron was especially marked during the first 24 hours. For delayed nausea, no significant difference between treatments was seen. No serious adverse effects were observed.

Adult↗
PubMed1991

Does dexamethasone enhance control of acute cisplatin induced emesis by ondansetron?

OBJECTIVE: To determine the contribution of dexamethasone to the efficacy of the 5-hydroxytryptamine antagonist ondansetron in control of cisplatin induced nausea and vomiting. DESIGN: Randomised double blind crossover study. SETTING: Two cancer centres in teaching hospitals, one in the United Kingdom and the other in Germany. SUBJECTS: 100 patients (53 men and 47 women) new to cisplatin chemotherapy, 84 of whom completed two consecutive courses of chemotherapy. INTERVENTIONS: Patients were given intravenous dexamethasone (20 mg) or physiological saline with intravenous ondansetron 8 mg before cisplatin, then ondansetron 1 mg/h for 24 hours. Oral ondansetron 8 mg was taken three times daily on days 2-6. MAIN OUTCOME MEASURES: Incidence of complete or major control of emesis (0-2 episodes in the 24 hours after chemotherapy). RESULTS: Complete or major control was obtained in 49 out of 71 (69%) of patients after receiving ondansetron plus dexamethasone compared with 40 out of 71 (56%) when they were given ondansetron alone (p = 0.012). This effect was most pronounced in the first 12 hours after chemotherapy. Patients receiving the combination also had significantly less nausea. Of the 53 patients who expressed a preference, 38 (72%) preferred the combination treatment (p = 0.002) to ondansetron alone. The effect of ondansetron on delayed emesis was less pronounced. CONCLUSIONS: Dexamethasone makes a significant contribution to the efficacy of ondansetron in the control of acute platinum induced emesis.

Acute Disease↗
PubMed1987

[New cytostatic drugs. Status: 1986].

In oncology phase-II studies are planned for testing antitumor activity in a series of malignant tumors. Most important is the development of drugs from entirely new classes of chemicals, fermentation products etc. Clinical research with analogues of known cytotoxic drugs aims at broader spectra of activity and at decreased toxicity in an attempt to avoid, for example, the cardiac toxicity of the anthracyclines or the renal and gastrointestinal toxicities of cis-platinum.

Antibiotics, Antineoplastic↗
PubMed1985

[Primary chemotherapy of advanced squamous epithelial carcinomas of the head and neck].

Advanced stage squamous cell carcinomas of the head and neck have a particularly poor prognosis despite surgical and irradiation treatment. Over the last few years attempts have been made to improve the local control rate using primary chemotherapy. 70 patients with advanced carcinomas were treated with methotrexate, cisplatin and bleomycin using double the dose of cisplatin as in the EORTC-study. The remission rate for patients undergoing two treatment courses was 83%. Toxicity was moderate to low with additional intensive anti-emetic treatment. The combination is well suited for chemotherapy of advanced tumours of the head and neck in combined treatment programmes.

Adult↗
PubMed1985

Phase-I study of mafosfamide-cyclohexylamine (ASTA-Z-7557, NSC 345 842) and limited phase-I data on mafosfamide-lysine.

Mafosfamide-cyclohexylamine is a new oxazaphosphorine derivative. It was chosen for phase-I clinical testing because of an expected higher therapeutic index and lack of complete cross resistance in animal tumors compared to cyclophosphamide. The schedule consisted of a single iv dose repeated every three weeks. The compound was found to cause as it's dose limiting toxicity severe pain along the injected vein and acute irritation of mucous membranes. The maximal tolerated dose was around 1000 mg/m2 given as a slow infusion over 2-3 hours. Hematological toxicity was mild. A limited phase-I study with the lysine salt of mafosfamide showed an identical type of toxicity. Mafosfamide given iv in a high-dose intermittent schedule is of little interest for further clinical trials. It is probable, that the severe venous pain and the mucosal irritation are caused by the high local concentration of 4-hydroxy-cyclophosphamide or by a metabolite. An oxazaphosphorine derivative undergoing slower hydrolysis therefore leading to lower active drug concentrations within the injected vein may be more promising.

Adult↗
PubMed1984

[Psycho-oncology].

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Adaptation, Psychological↗
PubMed1984

Lack of response in nine patients with breast cancer treated with fibroblast interferon.

Nine patients with metastatic breast cancer were treated with a minimum of 6 X 10(6) U/day of beta-interferon (IFN-beta) for at least 6 weeks. In patients whose disease did not progress during this period treatment was continued to a maximum of 13 weeks, while in other patients doses were escalated. With daily treatments over 3 weeks the maximum tolerated dose was found to be around 60 X 10(6) U/day. Fever occurred regularly. The dose-limiting toxicities were granulocytopenia and increasing liver enzymes. No objective remissions were observed. One patient showed stable disease after her cancer en cuirasse had rapidly progressed under chemotherapy. One patient each with nasopharyngeal carcinoma and fibrous sarcoma were also treated without success. IFN-beta at this moderately toxic dose given over a period of 6-13 weeks is of no clinical value in the treatment of metastatic breast cancer in women.

Adult↗
PubMed1984

Microangiopathic hemolytic anemia, a frequent complication of mitomycin therapy in cancer patients.

Microangiopathic hemolytic anemia (MAHA) has long been recognized as a rare complication in far-advanced malignant tumors. Recently several patients have been described in whom MAHA and renal insufficiency developed as a result of mitomycin therapy. We here describe another five such cases among 50 patients treated with mitomycin. All five cases were observed among the 14 patients who had received four or more doses of the drug. We conclude that MAHA is a frequent and potentially fatal complication of long-term mitomycin treatment. Careful monitoring for the early appearance of schistocytes is mandatory as the syndrome tends to be self-limited if this therapy is discontinued early.

Adenocarcinoma↗
PubMed1982

[Hodgkin disease].

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Germany, West↗