Phase I study of monoclonal antibody-ricin A chain immunoconjugate Xomazyme-791 in patients with metastatic colon cancer.

The immunoconjugate XMMCO-791/RTA consists of ricin A chain bound to a murine monoclonal antibody MoAb 791T. This monoclonal antibody (MoAb) binds to a glycoprotein of 72 kD, which is expressed on human colorectal carcinoma, ovarian carcinoma, and osteogenic sarcoma. XMMCO-791/RTA was tested in a Phase I trial with proposed dose escalation steps of 0.

Treatment of osteoarthritis of the knee. A comparison of flurbiprofen and aspirin.

The analgesic efficacy of flurbiprofen (Ansaid, Upjohn) and aspirin were compared in a 12-week, double-blind, randomized, parallel, multicenter study of 147 patients with osteoarthritis of the knee. Flurbiprofen (73 patients) was administered two, three, or four times a day in total daily doses of 100, 150, or 200 mg; aspirin (74 patients) was also given two, three, or four times a day in total daily doses of 2,000, 3,000, or 4,000 mg. Flurbiprofen was found effective in controlling pain and other symptoms of osteoarthritis.

Flurbiprofen in the treatment of rheumatoid arthritis. A comparison with aspirin.

This large-scale, double-blind study compared 200 mg per day of flurbiprofen (Ansaid, Upjohn) with 4,000 mg per day of aspirin in 822 patients with definite or classical rheumatoid arthritis who were evaluated for up to 52 weeks. Overall response to therapy was similar in both groups. By the end of the study, however, significantly more patients remained in the flurbiprofen (54 percent) than in the aspirin group (40 percent).

Safety of flurbiprofen in the treatment of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. A summary of liver and kidney assay data.

The safety of flurbiprofen (Ansaid, Upjohn) was assessed after pooling data on kidney and liver function collected from nine separate phase III clinical trials involving 1,677 patients (941 receiving flurbiprofen and 736 receiving comparison drugs) with ankylosing spondylitis, osteoarthritis, or rheumatoid arthritis. Multiple categories were created to discern the effects of treatment, disease, age (under 60 and 60 years or older), and duration of exposure to flurbiprofen. No clinically significant trends in kidney or liver function were detected in any category following the administration of flurbiprofen.

Flurbiprofen in the treatment of acute gout. A comparison with indomethacin.

The relative efficacy and safety of flurbiprofen (Ansaid, Upjohn) and indomethacin were compared in 29 patients with monoarticular gouty arthritis of less than 48 hours' duration. A loading dose of 400 mg of flurbiprofen or 200 mg of indomethacin was administered for 24 hours, followed by 200 mg of flurbiprofen per day or 100 mg of indomethacin per day for a maximum of five days. Based on global assessment of improvement, at least 50 percent of patients in both treatment groups showed improvement within 24 hours.

Flurbiprofen in the treatment of ankylosing spondylitis. A comparison with indomethacin.

In this randomized, double-blind study, 57 patients with ankylosing spondylitis were evaluated after 26 weeks of treatment with either flurbiprofen (Ansaid, Upjohn) or indomethacin. Flurbiprofen administered four times a day in a total daily dose of 200 mg was effective in controlling the pain and associated symptoms of ankylosing spondylitis. Pain was adequately controlled in some patients following a total daily dose of 100 mg of flurbiprofen administered twice a day.

Flurbiprofen in the treatment of ankylosing spondylitis. A comparison with phenylbutazone.

Flurbiprofen (Ansaid, Upjohn), a potent new analgesic and anti-inflammatory agent, was compared with phenylbutazone in 90 patients with ankylosing spondylitis. In this double-blind, randomized, 26-week study, a total daily dose of 200 mg of flurbiprofen, administered three times daily, was as effective as 300 mg of phenylbutazone in controlling the pain and other symptoms of ankylosing spondylitis. In some patients, symptoms were adequately controlled by 150 mg of flurbiprofen per day, administered twice daily.

Pharmacokinetics of flurbiprofen.

Both radiolabeled and nonlabeled drug have been used to study the pharmacokinetics of flurbiprofen (Ansaid, Upjohn). Drug absorption is rapid, drug disappearance half-life is independent of oral dose, and the area under the plasma drug concentration versus time curve increases with increasing oral dose. Elimination of intact drug from the peripheral circulation is biphasic and rapid.

Flurbiprofen for the treatment of bone pain in patients with metastatic breast cancer.

Two investigators enrolled 26 women with metastatic breast carcinoma in a six-week, double-blind, placebo-controlled, crossover study of flurbiprofen (Ansaid, Upjohn) and placebo. The study was designed to determine the efficacy of flurbiprofen in reducing bone pain due to metastatic breast cancer. Pain score, overall performance, and concomitant use of narcotics were evaluated.

Treatment of acute shoulder syndrome with flurbiprofen.

A multi-dose, double-blind, randomized, placebo-controlled, multicenter study was conducted to evaluate 68 patients with acute bursitis or tendinitis following treatment with flurbiprofen (Ansaid, Upjohn) or placebo. Flurbiprofen was administered in a total daily dosage of 200 to 300 mg four times daily. Based on efficacy rating scales, flurbiprofen-treated patients had the greatest proportion of improvement at almost all time periods.

Phase I study using combination of hydroxyurea and 5-azacytidine (NSC-102816).

Thirteen patients were treated with a hydroxyurea -- 5-azacytidine combination in an attempt to show an increase in therapeutic efficacy of 5-azacytidine without increased bone marrow toxicity. Leukemic and nonleukemic patients were selected in order to compare the effect of a combination therapy on bone marrow. There was no clear-cut tumor response observed in evaluable patients.

Variation of levels of plasma guanosine diphosphate L-fucose:beta-D-galactosyl alpha-2-L-fucosyltransferase in acute adult leukemia.

We have measured plasma levels of an alpha-2-L-fucosyltransferase in 18 patients with acute adult leukemia at various clinical stages along with simultaneous bone marrow aspirations and biopsies. Patients in remission had significantly lower levels of this enzyme than did nonresponding or relapsing patients. Furthermore, plasma levels were correlated with percentage of marrow blast cells.

Hypnotic efficacy of triazolam and methyprylon ininsomniac in-patients.

The hypnotic effects of a new triazolobenzodiazepine, triazolam (Halcion) 0-5 mg and methyprylon 300 mg was compared in twenty oncologic in-patient volunteers with insomnia using the preference technique. On the first night of the two-night trial, or methyprylon was given on a double-blind basis and on the second night the patients received the alternate medication. Following each trial night the patients were interviewed in regard to their sleep.

Phase I study of 5-azacytidine (NSC-102816) using 24-hour continuous infusion for 5 days.

The biologic and antitumor activity of 5-azacytidine has been well demonstrated in the past. The drug at present is thought to be primarily cell cycle phase specific. This study was designed to eliminate undesirable side effects (mainly nausea and vomiting) occurring with a bolus dose and to confirm the recent findings of the relative stability of 5-azacytidine's solution with preserved biologic and antitumor activity.