Phase I study of recombinant gamma-interferon (rIFN-gamma).

A Phase I study of recombinant gamma-interferon was conducted in 35 patients with advanced malignancy. The schedule was twice weekly administered intravenously. Patients were assigned to six dose levels. The major toxicities were flu-like symptoms and were unrelated to dose. Other adverse reactions, such as myelosuppression, were dose dependent. The addition of a nonsteroidal anti-inflammatory agent did not ameliorate the symptoms at the highest dose level. Antitumor effects occurred in patients with gastric, duodenal, and breast carcinoma.

Interferon-alpha therapy of renal cancer.

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.

Comparative trial of the antiemetic effects of THC and haloperidol.

A prospective, randomized and double-blinded trial of the comparative effects of delta-9-tetrahydrocannabinol (THC) and haloperidol (H) was begun in February 1980. Patients were randomized to initially receive either THC or haloperidol with cross-over to the other agent after two courses. All patients evaluated efficacy and toxicity of each agent and those patients completing the study expressed a preference for either THC or haloperidol. All patients are receiving chemotherapeutic agents known to induce severe vomiting (cis-platinum, nitrogen mustard, or doxorubicin) or have a history or retching with chemotherapy. Fifty-two patients are evaluable as of October, 1980. THC and haloperidol were equally effective in controlling nausea and vomiting as judged by number of vomiting episodes, patient evaluation of efficacy, and patient preference. About 10% of patients had complete control of vomiting and a third had less than five episodes. Patients failing one of the antiemetics had good control with the other about half the time. Toxicities from THC were less well tolerated than those from haloperidol, but most patients had no serious side effects. Nonoverlapping toxicities and efficacy raise the possibility that a combination of the agents might be worthwhile.